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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ during weeks 3 and 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during weeks 3 and 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement of abdominal pain as measured by 11-point numerical rating scale
Secondary outcome measures
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 moreSide effects data
From 2017 Phase 4 trial • 276 Patients • NCT030605126%
Abdominal pain
4%
Diarrhoea
4%
Abdominal pain upper
3%
Flatulence
2%
Headache
1%
Bronchitis
1%
Drug withdrawal syndrome
1%
Dry mouth
1%
Defaecation urgency
1%
Cough
1%
Nausea
1%
Non-cardiac chest pain
1%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Movantik
PEG 3350
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).
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,795 Previous Clinical Trials
6,373,858 Total Patients Enrolled
12 Trials studying Irritable Bowel Syndrome
874 Patients Enrolled for Irritable Bowel Syndrome
Stacy B Menees, MD, MSPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have certain medical conditions that can affect how your stomach and intestines work, such as inflammatory bowel disease or other diseases that affect the gastrointestinal system. You also have severe kidney or liver disease, or have had certain types of abdominal surgery in the past. Additionally, you are not allowed to take certain medications that can interfere with the study, like probiotics, antibiotics, or certain medications used for irritable bowel syndrome. You are also not eligible if you have recently started taking an antidepressant or are participating in another dietary therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Low FODMAP diet plus PEG 3350
- Group 2: Sham diet plus PEG 3350
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are currently involved in this research study?
"Affirmative, based on the information provided through clinicaltrials.gov this medical trial is still recruiting volunteers. The study was first posted on the 8th of November 2018 and has been modified as recently as April 1st 2022; 78 individuals are being sought after at a single location."
Answered by AI
Are participants currently being invited to join this experiment?
"This experiment, which was published on the 8th of November 2018 and revised on April 1st 2022 is actively looking for volunteers. The information can be found online at clinicaltrials.gov."
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