Inulin for Irritable Bowel Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how inulin, a type of fiber, affects gut bacteria and digestive processes in individuals with irritable bowel syndrome (IBS). Researchers aim to determine if changes in gut bacteria and the production of certain acids in the gut are linked to IBS symptoms. Participants will include individuals with IBS, either diarrhea- or constipation-predominant, and healthy individuals without gut issues. Those who have IBS symptoms and meet the Rome IV criteria (guidelines for diagnosing IBS) or are healthy with no digestive problems may be suitable candidates. As an unphased trial, this study seeks to explore new insights into IBS, offering participants the opportunity to contribute to groundbreaking research.
Will I have to stop taking my current medications?
You may need to stop taking certain medications that affect gastrointestinal function, like opioids, inflammatory drugs, or certain antidepressants, within 2 days before the study if you have IBS. However, stable low doses of antidepressants taken for more than a month may be allowed. Rescue medication for constipation is permitted if needed.
Is there any evidence suggesting that inulin is likely to be safe for humans?
Studies have shown that inulin, a type of dietary fiber, is generally easy for people to tolerate. Inulin supports good bacteria, improving gut health. Some individuals might experience mild side effects like bloating or gas, but these usually subside and often occur if introduced too quickly. Research indicates that daily fiber supplements like inulin are safe. However, one study found that a different type of fiber used in another trial caused more side effects and worsened symptoms for some individuals with IBS. Overall, inulin is considered safe for most people, but starting slowly and observing the body's response is advisable.12345
Why are researchers excited about this trial?
Most treatments for irritable bowel syndrome (IBS) focus on managing symptoms with medications like antispasmodics, laxatives, or anti-diarrheal drugs. However, inulin is unique because it is a natural dietary fiber that may help balance gut bacteria, which is thought to play a role in IBS symptoms. Researchers are excited about inulin because it offers a potentially more natural approach by promoting healthy digestion and gut health, rather than simply masking symptoms. Its ability to support a healthier gut environment could make it a promising alternative or complement to existing therapies.
What evidence suggests that inulin might be an effective treatment for irritable bowel syndrome?
Research has shown that inulin, a type of soluble fiber, can help alleviate irritable bowel syndrome (IBS) symptoms. Studies have found that inulin can increase weekly bowel movements and improve stool consistency, benefiting those with IBS. One study found that inulin intake made bowel movements more regular and consistent, as measured by the Bristol Stool Form Scale. However, some research suggests that the improvements might not differ significantly from a placebo, indicating that results can vary among individuals. Overall, many guidelines recommend soluble fiber like inulin as a good first step in managing IBS symptoms.
In this trial, researchers will divide participants into groups, including healthy volunteers and IBS patients with either diarrhea (IBS-D) or constipation (IBS-C), to evaluate inulin's effects on these specific conditions.12467Are You a Good Fit for This Trial?
Adults aged 18-65 with IBS, meeting Rome IV criteria for the condition, can join this study. It's also open to people without symptoms as control volunteers. Participants should be able to follow a specific diet and provide stool samples.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dietary Challenge
Participants follow a low fiber, high fat diet and record stool symptoms and patterns
Inulin Challenge
Participants ingest inulin and provide stool samples for analysis
Follow-up
Participants are monitored for dietary recall and stool characteristics
Optional Dietary Follow-up
Participants complete an optional dietary assessment using the ASA24 tool
What Are the Treatments Tested in This Trial?
Interventions
- Inulin
Inulin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
- Dietary supplement
- Prebiotic
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor