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Low FODMAP Diet + PEG 3350 for IBS with Constipation

N/A
Recruiting
Led By Stacy B Menees, MD, MS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during weeks 3 & 4

Summary

This trial will test the efficacy of PEG 3350 + a diet low in fermentable oligo, di, monosaccharides, and polyols (FODMAP) vs. PEG 3350 plus sham diet for Irritable Bowel Syndrome with Constipation (IBS-C).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed for this trial, generally speaking PEG 3350 can cause bloating, gas, upset stomach and cramping. The Low FODMAP diet may lead to initial hunger or dissatisfaction due to dietary restrictions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during weeks 3 and 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and during weeks 3 and 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement of abdominal pain as measured by 11-point numerical rating scale
Secondary study objectives
Bloating
Composite endpoint: Full responder was defined as a patient with >3 SBM per week, an increase of ≥1 SBM per week and >30% pain reduction.
HADS score
+8 more

Side effects data

From 2017 Phase 4 trial • 276 Patients • NCT03060512
3%
Flatulence
2%
Nausea
2%
Abdominal pain
1%
Urinary tract infection
1%
Abdominal pain upper
1%
Diarrhoea
1%
Vertigo
1%
Gastroenteritis
1%
Laceration
1%
Vomiting
1%
Abdominal distension
1%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
PEG 3350
Movantik

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Low FODMAP diet plus PEG 3350Experimental Treatment1 Intervention
Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).
Group II: Sham diet plus PEG 3350Placebo Group1 Intervention
Subjects will follow a sham diet and will take PEG 3350 (Miralax).

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,855 Previous Clinical Trials
6,434,983 Total Patients Enrolled
Stacy B Menees, MD, MSPrincipal InvestigatorUniversity of Michigan

Media Library

Low FODMAP diet/PEG 3350 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03687814 — N/A
IBS with constipation Research Study Groups: Low FODMAP diet plus PEG 3350, Sham diet plus PEG 3350
IBS with constipation Clinical Trial 2023: Low FODMAP diet/PEG 3350 Highlights & Side Effects. Trial Name: NCT03687814 — N/A
Low FODMAP diet/PEG 3350 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03687814 — N/A
~1 spots leftby Jan 2025
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