The Effect of Inulin Supplementation in Individuals With IBS-C

NCT ID: NCT06945302

Last Updated: 2025-04-25

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

Background: This study aimed to evaluate the effects of inulin supplementation on nutritional intake, anthropometric parameters, and bowel symptoms in individuals diagnosed with IBS-C.

Method: This was a randomised, single-blind, placebo-controlled clinical trial. Participants were randomly allocated into intervention (inulin) and control (placebo) groups for 8 weeks. Assessments included dietary intake, anthropometric measurements, and IBS symptoms.

Detailed Description

Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal disorder characterised by chronic abdominal pain, bloating, and altered bowel habits, often without identifiable organic pathology. IBS with predominant constipation (IBS-C) presents management challenges due to its multifactorial aetiology and impact on quality of life.

Inulin, a naturally occurring prebiotic dietary fibre found in many plants, has been studied for its beneficial effects on gut health, bowel function, and body composition. It may increase short-chain fatty acid production, improve intestinal transit, and promote beneficial gut microbiota such as Bifidobacteria. However, evidence on the specific benefits of inulin supplementation in individuals with IBS-C remains limited.

Inclusion criteria were being between the ages of 19-65 years, volunteering to participate in the study, being diagnosed with IBS by a physician according to Rome IV criteria, and having two of the three criteria according to Rome IV criteria: associated with defecation (alleviation), associated with change in defecation frequency, associated with change in stool appearance / symptoms started at least 6 months before the diagnosis was made and recurrent abdominal pain at least 1 day a week for the last 3 months. Exclusion criteria were a history of gastrointestinal surgery (except appendectomy and cholecystectomy), inflammatory bowel disease, lactose malabsorption, gastroenteritis, celiac disease, gastric and duodenal ulcer, metabolic diseases (cardiac, hepatic and renal diseases, diabetes, etc.), malignancy. ), history of malignancy, pregnancy and lactation, use of intestinal motility and 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, and use of prebiotic and probiotic supplements in the last 3 months.

In this study, eligible participants were randomly allocated into two groups:

• Intervention group (n=17): received 9.2 g/day of an inulin-oligofructose mixture (50:50), split into two doses daily.
• Control group (n=17): received an isocaloric placebo (maltodextrin, 9.2 g/day) using the same dosing schedule.

The intervention period was 8 weeks, during which participants continued their usual dietary habits. Assessments included dietary intake evaluations, anthropometric measurements (weight, BMI, waist and hip circumference, body composition via bioelectrical impedance), and IBS symptoms (using the IBS-SSS) at baseline and after 8 weeks.

The primary outcome was the change in IBS symptom severity (IBS-SSS scores). Secondary outcomes were changes in anthropometric parameters and dietary intake.

Conditions

Inulin; IBS (Irritable Bowel Syndrome); Nutritional Status; Anthropometric Measurement

Study Design

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

Study Groups

Intervention 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

Intervention 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.

Control

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

Control group (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

Intervention 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

Control group (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)

References

Merdol, T.K. (2011). Standard meal schedules for institutions (4. edt). Ankara: Hatipoğlu Publishing.

Reference Type: RESULT

Rakıcıoğlu, N., Acar Tek, N., Ayaz, A., Pekcan, G. (2012). Food and nutrient photo catalog. Ankara: Hatiboğlu Publishing.

Reference Type: RESULT

World Health Organization (WHO). (2011). Waist circumference and waist-hip ratio: report of a WHO expert consultation, Geneva, 8-11 December 2008.

Reference Type: RESULT

Bjelica, D., Popović, S., Kezunović, M., Petković, J., Jurak, G., & Grasgruber, P. (2012). Body height and its estimation utilising arm span measurements in Montenegrin adults. Anthropological Notebooks, 18(2).

Reference Type: RESULT

Other Identifiers

2021-377

Identifier Type: -

Identifier Source: org_study_id