Low FODMAP Diet + PEG 3350 for IBS with Constipation

Overseen By Amy Liu, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

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

Disqualifiers: Pregnancy, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a Low FODMAP diet combined with the laxative PEG 3350 can better manage symptoms of Irritable Bowel Syndrome with Constipation (IBS-C) compared to PEG 3350 with a placebo diet. Researchers seek to understand if reducing certain sugars in foods (FODMAPs) alleviates constipation-related symptoms. They are looking for participants who have experienced frequent abdominal pain, constipation, and hard stools for at least three months. This study will help determine if dietary changes can improve life for those with IBS-C. As an unphased trial, it offers a unique opportunity to contribute to understanding dietary impacts on IBS-C.

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.

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

Research has shown that the low FODMAP diet is generally safe for managing IBS symptoms. However, improper adherence might lead to a lack of certain nutrients. FODMAPs are specific carbohydrates that can cause gut issues like bloating and pain in people with IBS. Avoiding these can help some individuals feel better.

Conversely, PEG 3350, commonly known as Miralax, is a laxative safe for most people with IBS-C. It alleviates constipation but might not ease bloating or pain and could sometimes worsen these symptoms. Overall, both the diet and the laxative are usually well-tolerated, but correct adherence is important to avoid potential problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining a low FODMAP diet with PEG 3350 for IBS with constipation because this approach directly targets dietary triggers while providing a gentle laxative effect. Current treatments like fiber supplements and antispasmodics mainly focus on symptom relief, but the low FODMAP diet aims to reduce the root cause of symptoms by eliminating certain fermentable carbohydrates. Additionally, PEG 3350 offers a non-stimulant option to ease constipation, which is a different approach from some traditional laxatives that can have harsher effects. This combination could offer a more tailored and potentially effective management strategy for those suffering from IBS with constipation.

What evidence suggests that this trial's treatments could be effective for IBS-C?

This trial will compare the effects of a Low FODMAP diet plus PEG 3350 with a Sham diet plus PEG 3350 for individuals with IBS-C (Irritable Bowel Syndrome with Constipation). Research has shown that a low FODMAP diet can significantly benefit people with IBS-C, with up to 86% of patients reporting improvements, including less stomach pain and bloating. PEG 3350, also known as Miralax, is a common treatment for constipation and works effectively with regular use. Combining a low FODMAP diet with PEG 3350 has improved IBS-related quality of life and reduced anxiety more effectively than PEG 3350 alone. This combination addresses food triggers and helps maintain regular bowel movements. ^{1 2 6 7 8}

Who Is on the Research Team?

Stacy B Menees, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Low FODMAP diet/PEG 3350
• sham diet/PEG 3350

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03687814

Low FODMAP Plus PEG 3350 for the Treatment of Patients ... The PEG 3350 and low FODMAP diet group will achieve greater improvements in IBS related quality of life and anxiety than the group receiving PEG 3350 and the ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/227782

Low FODMAP Plus PEG 3350 for the Treatment of Patients ... Compare the proportion of patients with IBS-C on a diet of low FODMAP diet plus PEG 3350 vs. sham diet plus PEG 3350 reporting an improvement of abdominal pain.

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/227782

Low FODMAP Plus PEG 3350 for the Treatment of Patients ... Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4918736/

Efficacy of the low FODMAP diet for treating irritable bowel ... Up to 86% of patients with IBS find improvement in overall gastrointestinal symptoms as well as individual symptoms such as abdominal pain, bloating, ...

5. withpower.com withpower.com/trial/early-phase-1-irritable-bowel-syndrome-10-2018-53fd5

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8593809/

Prevalence, clinical characteristics, and management of ... Consequently, FODMAPs yield gas and fluid changes within the gut, contributing to the common symptoms of IBS such as pain, bloating, distension, and diarrhea.

7. webfiles.gi.org webfiles.gi.org/links/PCC/ACG_Clinical_Guideline__Management_of_Irritable.11.pdf

ACG Clinical Guideline: Management of Irritable Bowel ... We recommend a limited trial of a low fermentable oligosaccharides, disacchardies, monosaccharides, polyols (FODMAP) diet in patients with IBS ...

8. goodrx.com goodrx.com/conditions/irritable-bowel-syndrome/miralax-irritable-bowel-syndrome-ibs?srsltid=AfmBOoopIvJvQWoRz-XnBvvwMjatJaIFB29TRf3rmccnvzXOMieNkR_Q

Miralax for Irritable Bowel Syndrome (IBS): Does It Help? Miralax is safe for most people with IBS-C. But keep in mind that it won't help with bloating or pain. In some cases, it might make these ...