Clinical trial NCT06610188: The Effect of Inulin in Irritable Bowel Syndrome
Official title: The Effect of Inulin on Intestinal Symptoms, Depression and Quality of Life in Individuals With Constipation-Predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bowel Symptoms
Depression Disorders
Inulin
Constipation
Quality of Life (QOL)
Irritable Bowel Syndrome (IBS)
Keywords: Bowel symptoms
depression
inulin
constipation-predominant IBS
quality of life
Lead sponsor: Mardin Artuklu University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Individuals were randomly assigned to one of two groups: prebiotic (n=17) and placebo (n=17) groups.
Primary purpose: TREATMENT

Brief 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.

Detailed description: In the treatment of IBS, a multimodel perspective that includes psychological support (cognitive behavioural therapy, stress management techniques, etc.) in addition to lifestyle changes (dietary changes, etc.) may be beneficial.

Eligibility criteria: 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.

Primary outcomes:
measure: IBS-Visual Analogue Scale (IBS-VAS)
timeFrame: 8 weeks
measure: The Irritable Bowel Syndrome Symptom Severity Score (IBS/SSS)
timeFrame: 8 weeks
measure: Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL)
timeFrame: 8 weeks
measure: The Bristol Stool Scale
timeFrame: 8 weeks
measure: The Beck Depression Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Artuklu University
Study officials:
References: