Effect of Chicory-derived Inulin on Abdominal Sensations and Bowel Motor Function

Study Overview
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Brief Summary
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Subjects with gas-related complaints exhibit impaired handling of intestinal gas loads and we hypothesized that inulin would have a beneficial effect. Aim: to determine the effect of a prebiotic chicory-derived inulin-type fructan on the tolerance of intestinal gas. Methods. Placebo-controlled, parallel, randomized and double-blind trial study. Subjects with abdominal symptoms and reduced tolerance of intestinal gas (selected by a pre-test) will receive either inulin (8 g/d, n=18) or maltodextrin as a placebo (8 g/d, n=18) for 4 wk. A gas challenge test (4 h jejunal gas infusion at 12 mL/min while measuring abdominal symptoms and gas retention for 3 h) will be performed before and at the end of the intervention phase. Gastrointestinal symptoms and bowel habits (using daily questionnaires for 1 wk) and fecal bifidobacteria counts will be measured before and at the end of the intervention.

Official Title
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Efecto de Fructanos Paralelamente Hidrolizados Provenientes de Achicoria Sobre Las Sensaciones Abdominales

Conditions
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Functional Gastrointestinal Disorders

Intervention / Treatment
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* Dietary Supplement: Inulin
* Dietary Supplement: Maltodextrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: negative sensation of digestive well-being (score ≤ 1 on at least 2 of the 6 evaluation days, scored on a - 5 / +5 scale. poor tolerance of a gas challenge test (abdominal perception score ≥ 3, on a 0-6 scale, for at least three 15-min time points over the last 90 minutes of the 180-minute-long intestinal gas infusion test). Exclusion Criteria: antibiotic intake, exceptional diets, changes in dietary habits or intake of Ca supplements over the preceding month.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inulin 8 g/d<br>Mixture of oligo- and polysaccharides composed of fructose units connected by β (2→1) links with a total number of fructose and glucose units ranging between 2 and 70. | Dietary Supplement: Inulin<br>* Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period<br>|
| Placebo Comparator: maltodextrine 8 g/d<br> | Dietary Supplement: Maltodextrine<br>* Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perception of intestinal gas infusion | Effect of inulin intake (change from baseline with inulin versus placebo) on the tolerance of the gas challenge test, measured as the perception score of digestive sensations during the gas challenge test. At each time point, the highest score instead of the mean or cumulative scores will be computed for comparisons; these scores will be averaged over the last 60 min of the test in each subject; the differences between basal and intervention periods (inulin or placebo) will be calculated. | 60 last min of the 180 min gas infusion test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intestinal gas retention | Effect of inulin intake (change from baseline with inulin versus placebo) on the volume of gas retention (volume infused minus volume evacuated) measured as the average value over the last 60 min of the gas infusion test. | 60 last min of the 180 min gas infusion test | 
| Digestive well-being | Effect of inulin intake (change from baseline with inulin versus placebo) on digestive well-being measured by daily questionnaires on - 5 to + 5 score scales and averaged over 6 days. | 6 last days of intervention | 
| Abdominal discomfort | Effect of inulin intake (change from baseline with inulin versus placebo) on abdominal discomfort measured by daily questionnaires on 0 to 10 score scales and averaged over 6 days. | 6 last days of intervention | 
| Bowel habit | Effect of inulin intake (change from baseline with inulin versus placebo) on the number of bowel movements measured by daily questionnaires during 6 days. | 6 last days of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal gas, functional gut symptoms, intestinal sensitivity, intestinal motility