BridgeMD
New treatment option for Irritable Bowel Syndrome Characterized by Constipation
Official title Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
ClinicalTrials.gov ID: NCT03687814
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. people 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...
You likely can't join if
- any other IBS subtype other than IBS-C
- \>3 spontaneous bowel movements during the last 7 days of run-in
- Have cognitive dysfunction or unable to understand or provide written informed consent
- Pregnancy (evaluated by self-report)
- Comorbid medical problems that may affect gastrointestinal transit or motility:
- Inflammatory bowel disease
See the full eligibility criteria
- 1\. people 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
- any other IBS subtype other than IBS-C
- \>3 spontaneous bowel movements during the last 7 days of run-in
- Have cognitive dysfunction or unable to understand or provide written informed consent
- Pregnancy (evaluated by self-report)
- Comorbid medical problems that may affect gastrointestinal transit or motility:
- Inflammatory bowel disease
- Extra-intestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.)
- Severe renal or hepatic disease
- Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery if performed more than six months prior to enrollment
- Previous treatment with the low FODMAP diet under a dietician guidance
- Concurrent medications not permitted including probiotics, antibiotics, prescription or over-the-counter medication for IBS, and narcotics
- New antidepressant use (less than 3 months on stable dose)
- Active participation in another form of dietary therapy
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.