Treatment for Hepatobiliary Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Nationwide Children's Hospital, Columbus, OH
Hepatobiliary Disorders+2 More
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether amoxicillin alone has an appreciable effect on upper gastrointestinal motility compared to placebo.

See full description

Eligible Conditions

  • Hepatobiliary Disorders
  • Functional Gastrointestinal Disorders (FGID)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hepatobiliary Disorders

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 3 secondary outcomes in patients with Hepatobiliary Disorders. Measurement will happen over the course of Within 6 months after study drug administration during data analysis phase of study.

30 minutes after study drug administration
Induction of phase III of the migrating motor complex
Hour 4
Adverse events after study drug administration
Month 6
Characteristics of the induced phase III of the migrating motor complex
Patient demographics

Trial Safety

Safety Progress

1 of 3

Other trials for Hepatobiliary Disorders

Trial Design

2 Treatment Groups

Amoxicillin
1 of 2
Placebo
1 of 2
Active Control
Non-Treatment Group

This trial requires 26 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Placebo
Other
A liquid placebo will be administered via a nasoduodenal catheter to patients based on random assignment.
Amoxicillin
Drug
A liquid preparation of amoxicillin will be administered during the study through a nasoduodenal catheter after random patient assignment.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 minutes after study drug administration
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 minutes after study drug administration for reporting.

Who is running the study

Principal Investigator
C. D. L.
Carlo Di Lorenzo, Pediatric Gastroenterologist
Nationwide Children's Hospital

Closest Location

Nationwide Children's Hospital - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received 1 prior treatment for Hepatobiliary Disorders or one of the other 2 conditions listed above. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Children aged 3-21 years referred to the Motility Department at Nationwide Children's Hospital for antroduodenal manometry testing

Patient Q&A Section

What is hepatobiliary disorders?

"These disorders may be classified by location of onset and by histological type. In the most common forms, portal hypertension and cholestasis of any cause are involved. Biliary obstruction may present with jaundice and pruritus (itch). A minority of these disorders are caused by intrahepatic or extrahepatic malignancy. Rarely cirrhosis, and very rarely steatosis and fibrosis, cause symptoms. The hepatic manifestations may be symptomatic even in the absence of underlying liver disease." - Anonymous Online Contributor

Unverified Answer

Can hepatobiliary disorders be cured?

"The incidence of these conditions warrants careful screening in the general population. Abnormal liver function tests indicate the presence of hepatocellular inflammation. With early treatment, the majority of patients will have a significant decrease in their liver function." - Anonymous Online Contributor

Unverified Answer

What causes hepatobiliary disorders?

"Overwhelming data support that HBV and HCV are two of the most relevant risk factors for development of hepatobiliary disorders. In addition to virus-related risk factors, other risk factors were identified, of which most deserve deeper investigation." - Anonymous Online Contributor

Unverified Answer

What are the signs of hepatobiliary disorders?

"Signs of portal hypertension include hepatic enlargement (particularly in cirrhosis or in patients with obstructive jaundice), enlargement of the spleen, ascites, splenomegaly and portal tenderness. In acute situations such as portal vein thrombosis, hepatomegaly and splenomegaly occur without tenderness while ascites is present. Abdominal fullness (painful abdominal fullness) is a sign of ascites secondary to portal hypertension and, with this, the diagnosis of ascites." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hepatobiliary disorders?

"Lifestyle changes should be first line for many, if not all, patients with liver diseases and cholelithiasis. Medications can be used to treat pruritus, pain and symptoms of cholelithiasis. In the more serious conditions (cirrhosis, fibrosis or portal hypertension) drugs will be reserved for specific patients or complications. Surgery will be indicated only in specific cases." - Anonymous Online Contributor

Unverified Answer

How many people get hepatobiliary disorders a year in the United States?

"Chronic liver diseases cause more than 1 of every 100 deaths in the United States and this number is expected to rise with time. Hepatobiliary surgeons and other clinicians are called upon to educate the public and the healthcare system about the devastating burden these diseases cause." - Anonymous Online Contributor

Unverified Answer

Is treatment safe for people?

"There is moderate evidence for the safety of long-term iron and ferritin treatment for non-anemic ID in this population. There is weak evidence that long-term iron or ferritin therapy for ID may have an important adverse effect on short-term ID." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hepatobiliary disorders?

"There are many different medical conditions for which clinical trials are available. Doctors should consider the risk-benefit ratio as they decide whether a patient fits the criteria to participate in a clinical trial. It is important for patients to be informed so their physicians know when to recommend testing." - Anonymous Online Contributor

Unverified Answer

Does hepatobiliary disorders run in families?

"Most of the disorders do run in families, but not all of them. The inheritance patterns can be extremely variable. Most of the disorders are caused by environmental factors that accumulate to make the predisposition to development and to disease expression. Inherited disorders can be a clue into the underlying disease mechanism. It is worthwhile to continue to investigate the molecular basis of these diseases in order to develop a clear preventive concept on the first place. These diseases could be better understood in the light of genetic studies to identify the loci that could be mapped in families, especially in a high-resolution manner. Then, by use of molecular techniques, the genetic factors that predispose to these diseases could be identified to give a clue on the disease mechanism." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Although the use of the treatments and combination of treatments is not common in the treatment of cholestatic jaundice, most of the observed studies have shown that in terms of efficacy to treat cholestatic jaundice no significant difference can be noted between any treatment with any other treatment. Therefore, to recommend these treatments, a thorough analysis needs to be carried out. The type of treatment chosen would depend on the severity of the disease." - Anonymous Online Contributor

Unverified Answer

How serious can hepatobiliary disorders be?

"Patients with serious hepatobiliary disorders frequently experience symptoms, which can be challenging when diagnosing. A combination of clinical judgement, a good understanding of the disease course and high medical diagnostic and consultation skills are necessary for achieving the optimum management of severe hepatobiliary disorders." - Anonymous Online Contributor

Unverified Answer

How does treatment work?

"Treatment for choledocholithiasis may be accomplished by a percutaneous technique wherein the goal is to disrupt the stone by using ultrasound-guided laparoscopic or endoscopic retrograde cholangiopancreatography. In patients with hepatolithiasis, we recommend ERCP and biliary drainage under anesthesia for biliary clearance followed by an ultrasound study of the biliary ducts during the following 24 to 48 hours with a repeat ERCP if necessary. As in the case of the pancreas, the primary goal is to disrupt the stone by using cholangioscopy and electrohydraulic lithotripsy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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