The Effect of Inulin in Irritable Bowel Syndrome

NCT ID: NCT06610188

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-03
• Study Completion Date: 2023-04-01

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.

Conditions

Bowel Symptoms; Depression Disorders; Inulin; Constipation; Quality of Life (QOL); Irritable Bowel Syndrome (IBS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Prebiotic group

products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Group Type: EXPERIMENTAL

Prebiotic group

Intervention Type: DIETARY_SUPPLEMENT

products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Placebo

products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags

Group Type: PLACEBO_COMPARATOR

Maltodextrin (Placebo)

Intervention Type: DIETARY_SUPPLEMENT

products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Interventions

Prebiotic group

products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Intervention Type: DIETARY_SUPPLEMENT

Maltodextrin (Placebo)

products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mardin Artuklu University

OTHER

Sponsor Role: lead

Responsible Party

Çağlar Akçalı

Assist. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mardin Artuklu University

Mardin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

377

Identifier Type: -

Identifier Source: org_study_id