Helidac

Curling Ulcer, Indigestion, Flatulence + 9 more

Treatment

16 FDA approvals

20 Active Studies for Helidac

What is Helidac

Bismuth subsalicylate

The Generic name of this drug

Treatment Summary

Tetracycline is an antibiotic used to fight bacterial infections. It works by preventing the bacteria from producing proteins that are essential for their growth. It binds to the ribosomes of the bacteria and blocks the production of certain proteins which stops the bacteria from multiplying. In addition, it can also damage the bacteria’s cell membrane, leading to the leakage of important cell components.

Topcare stomach relief original strength

is the brand name

image of different drug pills on a surface

Helidac Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Topcare stomach relief original strength

Bismuth subsalicylate

1989

4

Approved as Treatment by the FDA

Bismuth subsalicylate, also called Topcare stomach relief original strength, is approved by the FDA for 16 uses such as Curling Ulcer and Heartburn .

Curling Ulcer

Used to treat Duodenal Ulcer in combination with Metronidazole

Heartburn

Used to treat Heartburn in combination with Calcium carbonate

Upset stomach

Traveler's Diarrhea

Indigestion

Helicobacter Pylori Infection

Used to treat Helicobacter Pylori Infection in combination with Metronidazole

Gastroenteritis

Flatulence

Duodenal Ulcer

Used to treat Duodenal Ulcer in combination with Metronidazole

Heartburn

Used to treat Heartburn in combination with Calcium carbonate

Diarrhea

belching

Flatulence

gastrointestinal fullness

Diarrhea

Gastrointestinal distress

Effectiveness

How Helidac Affects Patients

Tetracycline is a short-term antibiotic that stops bacteria from growing by blocking the way proteins are made in the body. It attaches to a part of the bacteria's ribosome and prevents the bacteria from making proteins. It can also cause the bacteria's cell wall to break, causing the bacteria's inner contents to leak out.

How Helidac works in the body

Tetracycline works by blocking the assembly of proteins in bacteria. It is carried through the bacterial membrane and binds to the ribosome, stopping transfer RNA from joining with the ribosome-messenger RNA complex and halting protein synthesis.

When to interrupt dosage

The prescribed measure of Helidac is contingent upon the diagnosed condition, such as Bartonellosis, Skin Infections caused by Staphylococcus Aureus and Clostridium difficile Infection (CDI). The quantity of dosage differs as per the delivery approach featured in the table underneath.

Condition

Dosage

Administration

Gastrointestinal distress

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Gastroenteritis

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Diarrhea

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Diarrhea

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

gastrointestinal fullness

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

belching

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Curling Ulcer

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Indigestion

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Upset stomach

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Flatulence

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Helicobacter Pylori Infection

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Heartburn

, 52.5 mg/mL, 26.2 mg/mL, 105.0 mg/mL, 262.0 mg, 17.47 mg/mL, 35.0 mg/mL, 2.62 mg/mg, 525.0 mg, 17.5 mg/mL, 300.0 mg, 1.7 %, 524.0 mg, 52.5 mg, 262.4 mg, 17.66 mg/mL, 17.6 mg/mL, 35.2 mg/mL, 23.6 mg/mL, 0.262 mg/mg

Oral, Suspension, Suspension - Oral, , Liquid, Liquid - Oral, Tablet, Tablet - Oral, Tablet, chewable, Tablet, chewable - Oral, Powder, Powder - Oral, Kit, Tablet, film coated - Oral, Tablet, film coated, Kit - Oral, Capsule, liquid filled - Oral, Capsule, liquid filled, Capsule, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Capsule - Oral, Tablet, coated - Oral, Tablet, coated, Syrup, Syrup - Oral, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated - Oral; Topical, Oral; Topical, Cream; Kit; Liquid; Ointment; Tablet; Tablet, chewable; Tablet, film coated

Warnings

Helidac Contraindications

Condition

Risk Level

Notes

Stomach Ulcer

Do Not Combine

Blood in Stool

Do Not Combine

Pulse Frequency

Do Not Combine

Melena

Do Not Combine

Fever

Do Not Combine

Gastrointestinal Hemorrhage

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Bismuth Subsalicylate may interact with Pulse Frequency

There are 20 known major drug interactions with Helidac.

Common Helidac Drug Interactions

Drug Name

Risk Level

Description

Bismuth subcarbonate

Major

Bismuth subsalicylate may increase the neurotoxic activities of Bismuth subcarbonate.

Bismuth subcitrate potassium

Major

Bismuth subsalicylate may increase the neurotoxic activities of Bismuth subcitrate potassium.

Bismuth subgallate

Major

Bismuth subsalicylate may increase the neurotoxic activities of Bismuth subgallate.

Bismuth subnitrate

Major

Bismuth subsalicylate may increase the neurotoxic activities of Bismuth subnitrate.

Probenecid

Major

The therapeutic efficacy of Probenecid can be decreased when used in combination with Bismuth subsalicylate.

Helidac Toxicity & Overdose Risk

The lowest toxic dose of the drug in mice has been found to be 808mg/kg when administered orally.

image of a doctor in a lab doing drug, clinical research

Helidac Novel Uses: Which Conditions Have a Clinical Trial Featuring Helidac?

There are 45 active trials assessing the potential of Helidac to treat Klebsiella Infections, Rocky Mountain Spotted Fever and Granuloma Inguinale.

Condition

Clinical Trials

Trial Phases

Gastroenteritis

12 Actively Recruiting

Phase 1, Phase 2, Not Applicable, Early Phase 1

Curling Ulcer

0 Actively Recruiting

Diarrhea

0 Actively Recruiting

Diarrhea

0 Actively Recruiting

gastrointestinal fullness

0 Actively Recruiting

Indigestion

6 Actively Recruiting

Phase 3, Not Applicable, Phase 2

Helicobacter Pylori Infection

2 Actively Recruiting

Not Applicable, Phase 4

Flatulence

0 Actively Recruiting

Heartburn

2 Actively Recruiting

Phase 3, Not Applicable

Upset stomach

0 Actively Recruiting

belching

0 Actively Recruiting

Gastrointestinal distress

9 Actively Recruiting

Phase 2, Early Phase 1, Phase 1, Phase 3, Not Applicable, Phase 4

Helidac Reviews: What are patients saying about Helidac?

5

Patient Review

7/28/2009

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I decided to stop taking this medication after only a few days. I was experiencing some unpleasant side effects like green stools and fatigue, and after reading other reviews about even more severe reactions like cramps, black tongues, and darkening teeth, I didn't feel it was worth it to continue.

3

Patient Review

5/4/2010

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I'm not particularly enjoying this treatment, as it's made me feel quite fatigued and given me stomach cramps. However, I am seeing some positive results and am hopeful that I will continue to improve.

2.7

Patient Review

8/2/2009

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I did experience the dark stool and some darkening of my tongue, which I had read could be potential side effects of the medication. However, I had no other problems besides a little nausea if I didn't eat. Overall, I'm not sure if the problem has been corrected yet but time will tell.

2.3

Patient Review

6/4/2009

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

My bowel movements have been loose and black since starting this medication, and I'm constantly feeling nauseous and tired.

2.3

Patient Review

5/1/2010

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I stopped taking this medication after only ten days due to the significant lack of energy I experienced. I would find myself in bed all day, and other side effects included black stool, nausea, and stomach cramps. I don't know if the short duration of treatment helped me or not; I'll have my stool tested again in a month and update my experience.

2.3

Patient Review

10/2/2010

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

It can be difficult to remember to take this medication, but it's essential. The yellow and black capsule made my symptoms worse, so I had to stop taking it. Just having to take it four times a day was hard enough.

2.3

Patient Review

1/25/2013

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

The side effects of this medication were unfortunately more intense than the benefits I experienced. For example, I had diarrhea for two weeks straight, as well as black tongue and abdominal pain so bad that it was excrutiating.

2

Patient Review

5/15/2009

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

The side effects were really tough to deal with, but I pushed through and took the pills every day. Unfortunately, even after completing the treatment, I didn't see any results.

1.7

Patient Review

6/2/2009

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

Since starting this medication, my bowel movements have not been normal. They've either been loose or liquid, and a very strange green color. In addition to that, I frequently feel bloated and full, and have experienced cramping and pain. To be honest, I actually felt better before beginning this medication.

1.7

Patient Review

6/8/2010

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I'm five days into this therapy and have had some nausea, which is tolerable. I'm also allergic to one of the medications in the therapy; it's caused a rash and itching that isn't tolerable, but the alternative treatment isn't an option for me. Once I finish the treatment, I'll be able to provide a more accurate review.

1

Patient Review

6/17/2010

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I have been taking this medication for 10 days now, and I can't say that it's helped me at all. If anything, it's made things worse - I'm having trouble eating and sleeping, and now I'm experiencing pain and cramping in my stomach.

1

Patient Review

8/3/2010

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

I would strongly recommend getting a second opinion before taking this medication. The side effects are incredibly painful and made my ulcer feel even worse.

1

Patient Review

4/6/2009

Helidac for Ulcer of Duodenum caused by Bacteria Helicobacter Pylori

Patient Q&A Section about helidac

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is helidac used for?

"Helidac is a prepackaged medication that contains three different antibacterials: bismuth subsalicylate, metronidazole, and tetracycline. These medications work together to treat peptic ulcers caused by Helicobacter pylori (H. pylori) infections. It needs to be taken with an antacid medication (e.g., H2 antagonist)."

Answered by AI

What is Pylera used to treat?

"This capsule treats and prevents stomach/intestinal ulcers caused by the bacteria H. pylori. The three medications in the capsule are bismuth subcitrate, metronidazole, and tetracycline."

Answered by AI

What is in a Prevpac?

"The PREVPAC consists of a daily administration pack containing two PREVACID 30-mg capsules, four amoxicillin 500-mg capsules, USP, and two clarithromycin 500-mg tablets, USP, for oral administration."

Answered by AI

Is bismuth Subcitrate an antacid?

"Bismuth salts can help get rid of bacteria that cause stomach issues such as diarrhea and stomach ulcers. They also act as an antacid for problems like indigestion."

Answered by AI

Clinical Trials for Helidac

Image of Stanford Digestive Health Clinic in Redwood City, United States.

MITI-001 for Irritable Bowel Syndrome

18 - 65
All Sexes
Redwood City, CA

While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and/or perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms. MITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.

Phase < 1
Waitlist Available

Stanford Digestive Health Clinic (+1 Sites)

Sean P Spencer, MD, PhD

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We made a collection of clinical trials featuring Helidac, we think they might fit your search criteria.
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Image of Mayo Clinic in Rochester in Rochester, United States.

High Resolution Gastric Mapping and Gastroduodenal Manometry for Indigestion

18 - 80
All Sexes
Rochester, MN

Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia. The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).

Recruiting
Has No Placebo

Mayo Clinic in Rochester

Nicholas R Oblizajek, MD

Image of Montefiore Medical Center in Bronx, United States.

Fosaprepitant vs Metoclopramide for Nausea and Vomiting

18+
All Sexes
Bronx, NY

The study team proposes a double-blind, comparative effectiveness, randomized controlled trial (RCT) to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic metoclopramide. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in emergency departments (EDs). Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time.

Phase 4
Waitlist Available

Montefiore Medical Center (+1 Sites)

Benjamin Friedman, MD

Image of Brigham and Women's Hospital in Boston, United States.

Low Thermal Plasma for Marginal Ulcers

18+
All Sexes
Boston, MA

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.

Recruiting
Has No Placebo

Brigham and Women's Hospital

Christopher C. Thompson, MD, MSc

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We made a collection of clinical trials featuring Helidac, we think they might fit your search criteria.
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Image of Montefiore Medical Center (Montefiore and Weiler EDs) in Bronx, United States.

Fosaprepitant for Nausea and Vomiting

18+
All Sexes
Bronx, NY

The study team proposes a randomized, double-blind, RCT to address the following goal: to determine the relative efficacy and adverse event profile of fosaprepitant compared to the standard of care antiemetic ondansetron. Fosaprepitant and its active metabolite aprepitant are a relatively new class of antiemetic that exclusively acts in the central nervous system by blocking neurokinin (NK-1) which is a key signaling molecule in the centrally mediated aspects of the vomiting reflex. Currently, fosaprepitant and aprepitant both have only two United Stated Food and Drug Administration (USFDA) approved indications for nausea and vomiting: chemotherapy-induced and postoperative. Neurokinin inhibitors are highly effective and generally well-tolerated. Therefore, this class of medication may be a more appropriate medication for the millions of patients with nausea and vomiting that seek care in EDs. Intravenous fosaprepitant is converted to the active metabolite aprepitant on the order of minutes and is significantly cheaper to procure at this time. The outcome for the efficacy analysis will be no need for additional medication to treat nausea and vomiting within 2 hours of investigational medication administration. The primary outcome for the tolerability analysis will be the development of any new symptom within 2 hours of medication administration.

Phase 2 & 3
Recruiting

Montefiore Medical Center (Montefiore and Weiler EDs) (+1 Sites)

Benjamin W Friedman, MD MS

Image of G. Oppenheimer Center for Neurobiology of Stress and Resilience in Los Angeles, United States.

Biofeedback for Functional Abdominal Bloating

18 - 80
All Sexes
Los Angeles, CA

Background. Abdominal distention is produced by an abnormal somatic postural tone. The authors developed an original biofeedback technique. In a randomized, placebo-controlled trial the authors demonstrated the superiority of biofeedback over placebo for the treatment of abdominal distention. However, the technique is technically complex and unpractical. Aim. To prove the efficacy of a noninstrumental biofeedback technique, transmitted by a standard training program, for the treatment of abdominal distension in different centers. Selection criteria. Episodes of visible abdominal distension. Intervention. Patients will be randomized into biofeedback and placebo groups. Three sessions of either biofeedback or placebo intervention will be performed during the first 3 weeks of the intervention period. Biofeedback: Patients will be taught to control abdominal and thoracic muscular activity by providing instructions using an original video support. In each center one operator will receive a standard training on how to deliver the noninstrumental biofeedback treatment. Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period. Placebo: Sham measurements of abdominal and thoracic motion will be performed, and a pill of placebo containing 0.21 g glucose will be administered; patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.

Recruiting
Paid Trial

G. Oppenheimer Center for Neurobiology of Stress and Resilience (+1 Sites)

Fernando Azpiroz, MD

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