CLINICAL TRIAL

Single Arm for Irritable Bowel Syndrome

Recruiting · 18+ · All Sexes · Calgary, Canada

Validation of the Small Intestine Microbiome Aspiration (SIMBA) Capsule

See full description

About the trial for Irritable Bowel Syndrome

Eligible Conditions
Irritable Bowel Syndrome · Proof of Concept

Treatment Groups

This trial involves 3 different treatments. Single Arm is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Control Group 1
Lactulose Breath Test
DIAGNOSTICTEST
+
Sedated EGD
PROCEDURE
+
Ingestible capsule
DEVICE
Control Group 2
Lactulose Breath Test
DIAGNOSTICTEST
+
Sedated EGD
PROCEDURE
+
Ingestible capsule
DEVICE
Control Group 3
Lactulose Breath Test
DIAGNOSTICTEST
+
Sedated EGD
PROCEDURE
+
Ingestible capsule
DEVICE

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No planned change in diet or medical interventions during the study duration.
Aged between 18 and 70 years.
Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushing.
Ability and willingness to meet the required schedule and study interventions.
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: within 5 days of primary measures
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: within 5 days of primary measures.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Single Arm will improve 1 primary outcome and 1 secondary outcome in patients with Irritable Bowel Syndrome. Measurement will happen over the course of same 1 day.

Bacterial density count
SAME 1 DAY
density count and comparison between capsule and stool sample (CFU/ml)
Bacterial composition
WITHIN 5 DAYS OF PRIMARY MEASURES
1. Correlation of hydrogen- and methane-producing bacteria species (by 16s RNA sequencing) found by SIMBA Capsule with hydrogen and methane concentrations (peak and rise in ppm) detected by LBT and bacterial density (CFU/ml) of endoscopic aspirate.

Patient Q & A Section

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

What are common treatments for proof of concept?

Treatments of proof of concept tend to be limited to medications. The use of antidepressants is limited to some extent. The use of antidepressants is commonly based on clinical impressions and is in line with previous research. There was no significant relationship between age and medication selection.\noriginal text: http://www.neurologyresearch2014.

Anonymous Patient Answer

Can proof of concept be cured?

The study shows that proof of concept with a new target may not be required in order to test the new pharmaceutical, but a proof that it fulfils the criteria for a proof of concept might be necessary.

Anonymous Patient Answer

What are the signs of proof of concept?

Data from a recent study shows that a small subset of patients are likely to benefit from this form of multimodal treatment in the pre-operative window. However, the number of treatments was small. The outcome measure had insufficient validity as a proxy for benefit in this large number of subjects.

Anonymous Patient Answer

What is proof of concept?

This is important if we are to use a proof of concept trial at the end of a clinical trial in support of its future use. This also makes sense for the use of an early stop for a trial where a sponsor is looking to stop a trial due to safety concerns. The main focus is to create trial results that have an impact on drug development and/or drug regulatory approval. This is also important when assessing the impact on patient outcomes.\n\nOn January 5, a second panel of reviewers was sent by a different journal to the journal editors and authors to assess whether the claims of both the review article and its appendix were appropriately described and represented.

Anonymous Patient Answer

How many people get proof of concept a year in the United States?

Almost 2 million people were enrolled in the study. There is an observed hazard ratio of 0.88 (95% confidence interval, 0.75 to 1.02) of developing clinical evidence of the trial drug compared with the placebo drug. Both the relative and absolute risk reductions are important, especially in light of the increasing trend of utilization of pharmaceutical therapies and the limited budget resources for clinical trials.

Anonymous Patient Answer

What causes proof of concept?

The proof of concept trial model is well suited for testing proof of concept therapeutics. A trial designed to test proof of concept is simple and cost effective, and can easily be designed and launched on time.

Anonymous Patient Answer

Have there been other clinical trials involving single arm?

There have been many clinical trials focusing on single arm studies. Many of these studies had no placebo controls and therefore cannot definitively demonstrate that the treatment was effective.

Anonymous Patient Answer

Have there been any new discoveries for treating proof of concept?

There is very little that has been discovered about treatments for POC of lupus. There is a strong need for clinical trials to explore POC treatments for both disease and symptoms.

Anonymous Patient Answer

What is the average age someone gets proof of concept?

The average person with [pancreas cancer] should be given proof of concept. It may take a few more years to be able to use the new treatment plan in daily practice. In order to be eligible for clinical trials, please search the [power] website first and find clinical trials that pertain to your type of cancer. When it comes time for enrollment, find out what you're eligible for in advance by following up on the answers to your questions. [Power] has a lengthy list of clinical trials in pancreatic cancer that are happening right now. For example, you're eligible for a clinical trial in a novel [targeted therapy] for advanced cancer in combination with radiation and chemotherapy.

Anonymous Patient Answer

Does proof of concept run in families?

There is only weak evidence for gene-gene interaction with the strongest genetic association for age-adjusted ovarian cancer risk occurring among individuals carrying a BRCA2 mutation.

Anonymous Patient Answer

Is single arm typically used in combination with any other treatments?

Single arm studies often combine with other treatments. Thus, the results of single arm studies are often inconclusive, and their effectiveness cannot be demonstrated. We suggest that single arm trials should be used in combination with other treatments.

Anonymous Patient Answer

How serious can proof of concept be?

As of 1 March, there had been 4,534,947 cases of the 2019-nCoV infection, of which 15% had died. Proof of concept is important, but proof of safety and effectiveness are still important goals in the fight against nCoV disease.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Irritable Bowel Syndrome by sharing your contact details with the study coordinator.