The Effect of Inulin in Irritable Bowel Syndrome (NCT06610188) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Inulin in Irritable Bowel Syndrome
Turkey (Türkiye)34 participantsStarted 2021-11-03
Plain-language summary
Purpose: This study was conducted to evaluate the effect of inulin on bowel symptoms, depression and quality of life in individuals with constipation-dominant irritable bowel syndrome. Individuals (n=34) aged 21-63 years with constipation-dominant IBS were included in the study. Individuals were divided into two groups as prebiotic group \[(n=17) (inulin/oligofructose 50/50 mixture of 4.6 g (Inulin=total 9.2 g) inulin/oligofructose 50/50 mixture twice a day)\], and placebo \[(n=17), (Maltodextrin=9.2 g)\] group. The intervention period was 8 weeks and Bristol Stool Scale, IBS-Visual Analogue Scale, IBS-Symptom Severity Score Scale (IBS-SSS), IBS-Quality of Life Scale (IBS-QoL) and Beck Depression Scale were administered to the participants at the beginning, 1st month and 2nd month. SPSS software programme was used for statistical analysis of the data. It is thought that inulin supplementation may be effective in reducing symptom severity and frequency, improving bowel function (stool frequency, consistency and transit time) and quality of life, and thus may be beneficial in individuals with constipation-predominant IBS.
Who can participate
Age range
19 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* the individuals were between 19-65 years of age
* volunteer to participate in the study
* Individuals diagnosed with IBS by a physician according to Rome IV criteria
Exclusion Criteria:
* a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
* inflammatory bowel disease
* lactose malabsorption
* gastroenteritis
* celiac disease
* gastric
* duodenal ulcer
* metabolic diseases (cardiac, hepatic and renal diseases, diabetes, etc.)
* history of malignancy
* pregnancy and lactation
* use of intestinal motility
* antidepressant drugs
* involuntary body weight loss of more than 5 kg in the last 3 months
* use of dietary fibre supplements in the last 3 months
* use of antibiotics in the last 3 months
* use of prebiotic and probiotic supplements in the last 3 months.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
IBS-Visual Analogue Scale (IBS-VAS)
Timeframe: 8 weeks
2
The Irritable Bowel Syndrome Symptom Severity Score (IBS/SSS)
Timeframe: 8 weeks
3
Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL)