Low FODMAP Diet + PEG 3350 for IBS with Constipation

Recruiting in Palo Alto (17 mi)

Overseen by Stacy B Menees, MD, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Must not be taking: Probiotics, Antibiotics, Narcotics, others

Disqualifiers: Pregnancy, Inflammatory bowel disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Consecutive patients with Irritable Bowel Syndrome with Constipation (IBS-C) will be recruited from the outpatient clinics of the University of Michigan Health System. Eligible patients will be asked to participate in a study that will test the efficacy the PEG 3350 + a diet low in fermentable oligo, di, monosaccharides, and polyols (FODMAP) vs. PEG 3350 plus sham diet. Blinding dietary advice trials is challenging and therefore the sham diet was based on the criteria set forth by Staudacher et al. which emphasizes that the diet must give the impression that is the true intervention diet with similar restrictions, modifications, and time intensity without impacting the intake of essential nutrients, fiber, and FODMAPs. An example of the sham diet's carbohydrates includes: apples, bananas, and pears, and wheat. Oranges, raspberries, strawberries and rice would not be allowed. Additionally, the physicians analyzing the data will be blinded as to which group the patients were randomized.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, including probiotics, antibiotics, any prescription or over-the-counter medication for IBS, and narcotics. If you are on a new antidepressant, you must have been on a stable dose for at least 3 months.

What data supports the effectiveness of the treatment Low FODMAP diet/PEG 3350 for IBS with Constipation?

Research shows that a low FODMAP diet can help manage symptoms of irritable bowel syndrome (IBS), such as bloating and diarrhea, and improve quality of life. While the studies focus on IBS in general, they suggest that this diet may also be beneficial for IBS with constipation. ^{1 2 3 4 5}

Is the Low FODMAP Diet + PEG 3350 safe for humans?

The Low FODMAP diet is generally considered safe for managing symptoms of irritable bowel syndrome (IBS), but it may lead to nutritional deficiencies if not properly managed, as it restricts many common foods. There is no specific safety data available for the combination of Low FODMAP diet and PEG 3350, but PEG 3350 is commonly used as a laxative and is generally safe for short-term use. ^{1 3 4 5 6}

How does the Low FODMAP Diet + PEG 3350 treatment for IBS with constipation differ from other treatments?

This treatment combines a low FODMAP diet, which reduces certain carbohydrates that can cause digestive issues, with PEG 3350, a laxative that helps relieve constipation. This dual approach targets both dietary triggers and constipation, making it unique compared to treatments that address only one aspect of IBS. ^{1 6 7 8 9}

Research Team

Stacy B Menees, MD, MS

Principal Investigator

University of Michigan

Eligibility Criteria

Adults diagnosed with IBS-C, experiencing recurrent abdominal pain and changes in bowel movement frequency or stool form. Participants must not have other conditions affecting the gut, severe kidney or liver disease, recent major surgery (except some minor types), previous low FODMAP diet treatment, certain medication use including for IBS, new antidepressants, or be pregnant.

Inclusion Criteria

Subjects aged 18 and older meeting the Rome IV criteria for IBS-C: Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following: related to defecation, associated with a change in the frequency of stool (reduction of stools), associated with a change in the form of stool (hard or lumpy stools) AND >25% hard stools and <25% loose stools * Criteria fulfilled for the last 3 months

Exclusion Criteria

You have a type of irritable bowel syndrome (IBS) called IBS-C.

You have had more than 3 unplanned bowel movements in the last week.

Cognitive dysfunction or unable to understand or provide written informed consent

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low FODMAP diet plus PEG 3350 or a sham diet plus PEG 3350

4 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Low FODMAP diet/PEG 3350 (Other)
• sham diet/PEG 3350 (Other)

Trial Overview The study compares the effectiveness of two treatments: a combination of PEG 3350 with a Low FODMAP diet versus PEG 3350 with a sham diet that mimics dietary restrictions without reducing essential nutrients. Patients are randomly assigned to one of these diets while physicians analyzing results won't know which group patients are in.

Participant Groups

Group I: Low FODMAP diet plus PEG 3350 Experimental Treatment 1 Intervention

Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).

Group II: Sham diet plus PEG 3350 Placebo Group 1 Intervention

Subjects will follow a sham diet and will take PEG 3350 (Miralax).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Findings from Research

In a study of 110 patients with diarrhea subtype of irritable bowel syndrome (IBS-D), a low FODMAP diet significantly improved gastrointestinal symptoms, stool frequency, and consistency compared to general dietary advice over a 6-week period.

Both dietary interventions led to symptom improvement, but the low FODMAP diet showed greater benefits, indicating it may be a more effective management strategy for IBS-D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low fermentable oligo-di-mono-saccharides and polyols diet versus general dietary advice in patients with diarrhea-predominant irritable bowel syndrome: A randomized controlled trial. Zahedi, MJ., Behrouz, V., Azimi, M.[2022]

A low FODMAP diet significantly improved symptoms in over 70% of patients with irritable bowel syndrome (IBS) and functional abdominal bloating, based on a study of 30 patients in Spain.

Good adherence to the low FODMAP diet was a key predictor of positive symptom response, highlighting the importance of following dietary recommendations for effective management of IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diet low in fermentable carbohydrates short chain and polyols improves symptoms in patients with functional gastrointestinal disorders in Spain]. Huamán, JW., Felip, A., Guedea, E., et al.[2022]

The low FODMAP diet significantly improved symptoms of irritable bowel syndrome (IBS), including reduced abdominal pain and bloating, and enhanced health-related quality of life in a study of 60 IBS patients over an 8-week period.

The diet was found to be more feasible for patients who had more time to dedicate to it, such as unemployed individuals or students, suggesting that motivation and lifestyle factors play a role in adherence to the diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Low Fermentable Oligosaccharide, Disaccharide, Monosaccharide, and Polyol Diet and Its Effects on Quality of Life in an Italian Cohort. Cingolani, A., Paduano, D., Vecchiarelli, V., et al.[2020]

The low-FODMAP diet can help alleviate symptoms of irritable bowel syndrome (IBS), such as bloating and diarrhea, but the evidence supporting its effectiveness is limited due to methodological flaws in studies, including a lack of proper control groups.

Prolonged use of the low-FODMAP diet may lead to nutritional deficiencies because it restricts many staple foods, potentially resulting in lower intake of essential nutrients like fiber, calcium, and vitamins, especially for those with limited access to alternative foods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Low FODMAP Diet: Many Question Marks for a Catchy Acronym. Catassi, G., Lionetti, E., Gatti, S., et al.[2022]

A low FODMAP diet significantly improved abdominal symptoms in patients with irritable bowel syndrome (IBS), non-active inflammatory bowel diseases (IBD), and celiac disease (CD) after 1 and 3 months, indicating its efficacy across these conditions.

The study involved 127 participants and showed that while initial symptom scores differed among the groups, the low FODMAP diet led to similar improvements in abdominal symptoms for all groups by the end of the study, suggesting it can enhance quality of life for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Irritable Bowel Syndrome: The Efficacy of the Low Fodmap Diet for Improving Symptoms in Inflammatory Bowel Diseases and Celiac Disease. Testa, A., Imperatore, N., Rispo, A., et al.[2018]

The FODMAP reduced diet is an effective treatment for irritable bowel syndrome (IBS), with 79% of patients reporting significant improvement in symptoms after 8 weeks, including reductions in abdominal pain and bloating.

Despite its efficacy, adherence to the FODMAP diet is low, with nearly half of the participants dropping out and 36% experiencing significant weight loss, highlighting the need for better support and monitoring for patients on this diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of FODMAP - reduced diet in irritable bowel syndrome - efficacy, adherence, and body weight course. Frieling, T., Heise, J., Krummen, B., et al.[2019]

A webinar on the low-FODMAP diet significantly improved IBS symptoms in 228 participants, with a 50.9% reduction in those rating their symptoms as moderate-to-severe after 8 weeks (p < 0.001).

Participants also reported better stool consistency and frequency, with normal stool consistency increasing from 23.2% to 39.9% and normal stool frequency from 76.3% to 89% post-webinar (both p < 0.001), indicating the webinar's effectiveness as a dietary intervention for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A dietitian-led low-FODMAP diet webinar: a pre-post study evaluating its impact on symptoms of irritable bowel syndrome. Colgan, A., Digby, K., Apekey, T., et al.[2023]

The low FODMAP diet is recognized as the first-line therapy for managing irritable bowel syndrome (IBS) symptoms, such as abdominal pain and bloating, and can significantly improve health and quality of life outcomes.

This dietary intervention is safe, inexpensive, and noninvasive, especially when monitored by a dietitian, making it an effective option for many individuals suffering from IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The low FODMAP diet: fundamental therapy in the management of irritable bowel syndrome. Ireton-Jones, C.[2018]

A structured individual low-FODMAP dietary advice (SILFD) was significantly more effective than brief dietary advice (BRD) in reducing IBS symptoms, with 60% of SILFD patients reporting a 30% decrease in abdominal pain compared to only 28% in the BRD group.

The SILFD not only improved overall IBS symptom severity but also significantly reduced the intake of high-FODMAP foods and lowered post-prandial hydrogen breath production, indicating a more effective management strategy for IBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Structural Individual Low-FODMAP Dietary Advice vs. Brief Advice on a Commonly Recommended Diet on IBS Symptoms and Intestinal Gas Production. Patcharatrakul, T., Juntrapirat, A., Lakananurak, N., et al.[2020]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Low fermentable oligo-di-mono-saccharides and polyols diet versus general dietary advice in patients with diarrhea-predominant irritable bowel syndrome: A randomized controlled trial. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[The diet low in fermentable carbohydrates short chain and polyols improves symptoms in patients with functional gastrointestinal disorders in Spain]. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Low Fermentable Oligosaccharide, Disaccharide, Monosaccharide, and Polyol Diet and Its Effects on Quality of Life in an Italian Cohort. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Low FODMAP Diet: Many Question Marks for a Catchy Acronym. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Beyond Irritable Bowel Syndrome: The Efficacy of the Low Fodmap Diet for Improving Symptoms in Inflammatory Bowel Diseases and Celiac Disease. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Tolerability of FODMAP - reduced diet in irritable bowel syndrome - efficacy, adherence, and body weight course. [2019]

7. England pubmed.ncbi.nlm.nih.gov

A dietitian-led low-FODMAP diet webinar: a pre-post study evaluating its impact on symptoms of irritable bowel syndrome. [2023]

8. England pubmed.ncbi.nlm.nih.gov

The low FODMAP diet: fundamental therapy in the management of irritable bowel syndrome. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Structural Individual Low-FODMAP Dietary Advice vs. Brief Advice on a Commonly Recommended Diet on IBS Symptoms and Intestinal Gas Production. [2020]