Skip to main content
OpenTrials
Completed

NCT Number: NCT06945302

The Effect of Inulin Supplementation in Individuals With IBS-C

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Artuklu University

Mardin, 47200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

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 group (placebo)

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.

Primary outcomes

  1. Irritable Bowel Syndrome - Symptom Severity Score/(IBS-SSS)

    Time frame: 8 week

    The IBS-SSS scale was used to assess the severity of irritable bowel syndrome symptoms. This scale consists of a total of 5 questions, each of which is scored between 0 and 100. The questions provide information about the severity and frequency of abdominal pain, the severity of abdominal distension, the level of satisfaction with bowel habits and the impact of the disease on quality of life. An increase in the score obtained from the scale indicates an increase in symptom severity. ROC (Receiver Operating Characteristic) analysis was applied for the cut-off point of the scale. Accordingly, the cut-off point was calculated as 217.5.

Secondary outcomes

  1. Outcome Measure 1: Height Measurement

    Time frame: 8 weeks

    Description: "The height of the participants was measured using an inflexible tape measure with their head, hips, and heels touching the wall, and their feet standing side by side and in the Frankfort plane."

    • Unit: centimeters
  2. Outcome Measure 2: Waist Circumference

    Time frame: 8 weeks

    Description: "The waist circumference was measured using a non-flexible tape measure with a sensitivity of 0.1 cm at the midpoint between the iliac crest and the lowest rib margin."

    • Unit: centimeters
  3. Outcome Measure 3: Hip Circumference

    Time frame: 8 weeks

    Description: "Hip circumference was measured at the widest point of the hips using a non-flexible tape measure."

    • Unit: centimeters
  4. Outcome Measure 4: Lean Body Mass

    Time frame: 8 weeks

    Description: "Lean body mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601)."

    • Unit: kilograms
  5. Outcome Measure 5: Body Fat Percentage

    Time frame: 8 weeks

    Description: "Body fat percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601)."

    • Unit: percentage (%)
  6. Outcome Measure 6: Total Body Water

    Time frame: 8 weeks

    Description: "Total body water percentage (%) assessed via bioelectrical impedance analysis (Tanita BC 601)."

    • Unit: percentage (%)
  7. Outcome Measure 7: Bone Mass

    Time frame: 8 weeks

    Description: "Bone mass (kg) assessed using bioelectrical impedance analysis (Tanita BC 601)."

    • Unit: kilograms
  8. Outcome Measure 8: BMI

    Time frame: 8 weeks

    Description: "Body mass index calculated from height and weight measurements (kg/m²)."

    • Unit: kg/m²
  9. Determination of Nutrient Consumption Status

    Time frame: 8 week

    In order to determine the nutritional status of the participants, 24-hour food consumption records were taken at the beginning of the study and one-day food consumption records were taken in the 8th week. In determining the ingredients and quantities of some of the meals consumed, the book 'Standard Recipes' was used. The meals cooked at home were calculated by asking questions. 'Food and Nutrient Photo Catalogue' was used in order to evaluate the consumption measurements and quantities of foods accurately. The calculation of energy, macro and micronutrient values of the foods consumed was done with the Computer Assisted Nutrition (BEBIS) programme.

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Registry information

Official study title

The Effect of Inulin Supplementation on Nutritional Status, Anthropometric Measurements and Bowel Symptoms in Individuals With IBS-C: RCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 25, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.