94 Participants NeededMy employer runs this trial

Dietary Therapies for Irritable Bowel Syndrome

PS
Overseen ByPrashant Singh, MBBS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets might affect individuals with irritable bowel syndrome (IBS). The researchers aim to determine if certain markers in stool or urine can track changes in how the body processes carbohydrates such as fructo-oligosaccharide and mannitol. Participants will follow either an elimination diet (Diet A) or a healthy eating diet (Diet B) to identify which diet better alleviates IBS symptoms. This trial suits individuals with IBS symptoms like diarrhea or constipation, excluding those with unexplained weight loss or rectal bleeding. Participants should not have followed specific diets like low-fat or gluten-free in the past six months. As an unphased trial, this study provides a unique opportunity to contribute to understanding dietary impacts on IBS without the constraints of traditional drug testing phases.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not make changes to your current IBS medications during the four-week study period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that elimination diets, such as Diet A, are generally safe and easy for people with irritable bowel syndrome (IBS) to follow. These diets often involve cutting out certain foods to help manage symptoms. Research indicates that they usually don't cause serious side effects and can actually reduce IBS symptoms, improving well-being.

Diet B, in contrast, emphasizes healthy eating. This approach is safe for most people and promotes balanced meals with plenty of fruits, vegetables, and whole grains. Healthy diets like this are known to support overall well-being without causing harm.

Both diets aim to safely help manage IBS symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about these dietary therapies for Irritable Bowel Syndrome (IBS) because they offer a more personalized and potentially effective approach compared to standard treatments like medication and generic dietary advice. Diet A, the elimination diet, focuses on removing specific foods that might trigger IBS symptoms, offering a tailored solution that directly targets individual food sensitivities. Meanwhile, Diet B emphasizes healthy eating habits, which may improve gut health and overall well-being without the need for medications. These dietary strategies could provide relief without the side effects often associated with conventional IBS treatments.

What evidence suggests that this trial's dietary therapies could be effective for irritable bowel syndrome?

Research has shown that elimination diets can help reduce symptoms of Irritable Bowel Syndrome (IBS). In this trial, participants will follow either Diet A, an elimination diet, or Diet B, a healthy eating diet. People on elimination diets often experience significant relief, with reduced stomach pain. One study found that 59.6% of participants on a specific elimination diet met their treatment goals, compared to 42.1% on a placebo diet. Another study found that this type of diet can improve the overall quality of life for those with IBS. Overall, elimination diets appear promising for effectively managing IBS symptoms.46789

Who Is on the Research Team?

PS

Prashant Singh, MBBS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 who have irritable bowel syndrome (IBS) of any type and moderate to severe symptoms. People with unexplained serious symptoms like rectal bleeding or weight loss can join only if recent tests showed no major problems.

Inclusion Criteria

I have IBS without unexplained bleeding, weight loss, or nighttime symptoms.
I am between 18 and 65 years old.
My IBS symptom score is 175 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either an elimination diet or a healthy eating diet to evaluate dietary compliance using biomarkers

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Diet A
  • Diet B

Trial Overview

The study compares two diets: an elimination diet that removes certain foods, and a general healthy eating diet. Researchers will check stool or urine samples to see if they can track changes in carbohydrate intake.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Diet A - elimination dietExperimental Treatment1 Intervention
Group II: Diet B - healthy eating dietActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

Citations

Efficacy of a Digital Personalized Elimination Diet for the Self ...

Primary outcomes. The digital personalized elimination diet program improved IBS and comorbid IBS/IBD symptoms statistically and clinically significantly for ...

The efficacy and real-world effectiveness of a diet low in ...

All three showed that the LFD had a greater effect in reducing IBS symptoms than habitual diet or control diets. Over a dozen new studies on the LFD in adults ...

Efficacy of dietary interventions in irritable bowel syndrome

In terms of dietary interventions for IBS, the most evidence exists for a low FODMAP diet, but other promising therapies are emerging and should ...

A Novel, IBS-Specific IgG ELISA-Based Elimination Diet in ...

A significantly greater proportion of subjects in the experimental diet group met the primary outcome than those in the sham diet group (59.6% vs 42.1%,. P ¼ .

Efficacy of a Restrictive Diet in Irritable Bowel Syndrome - PMC

A few RCTs have been conducted for these dietary restrictions and have reported efficacy in relieving the symptoms of patients with IBS. Although research shows ...

The Role of Diet in the Management of Irritable Bowel Syndrome

Elimination diets such as low FODMAP diets, gluten-free diets, and ... Mediterranean diet was found to be safe and well-tolerated among IBS patients.

Low FODMAPs Diet in IBS: Experts Disagree on Evidence ...

The low FODMAPs diet currently has the greatest amount of available data, yet experts continue to disagree on whether or not enough is known ...

The Ten Dietary Commandments for Patients with Irritable ...

IgG-Based Elimination Diet: Sometimes used in IBS to identify potential trigger foods, this approach may help alleviate symptoms, although scientific evidence ...

A Novel, IBS-Specific IgG ELISA-Based Elimination Diet in ...

This study aimed to assess the efficacy of an elimination diet by using a novel IBS-specific IgG assay.