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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inulin 8 g/d | Experimental | 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. |
|
| maltodextrine 8 g/d | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inulin | Dietary Supplement | Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Azpiroz, MD | Hospital Universitari Vall d'Hebron Research Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 |
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| Maltodextrine | Dietary Supplement | Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period |
|
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 |
| Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |