Effect of Consumption of Orafti® Inulin on Bowel Motor Function in Subjects With Constipation

Beneo

Status: Completed

Conditions: Healthy; Constipation

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Orafti® Inulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02548247

BTS528_10

Details and patient eligibility

About

Investigation of the effects of a four week daily consumption of Orafti® Inulin on bowel motor function in subjects with constipation.

Enrollment: 54 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers without clinical diagnosed diseases with relevant effect on the gastrointestinal system or on visceral motility.
• Constipation defined as an average of 2-3 stools per week. Volunteers should have had constipation for at least the previous 6 months.
• Age ≥ 20 and ≤ 75

Exclusion criteria

• Subject under prescription for medication for digestive symptoms such as antispasmodic, laxatives, anti-diarrheic drugs or other digestive auxiliaries.
• Relevant history, presence of any medical disorder or chronic intake of medication/dietary supplements potentially interfering with this trial.
• Subjects with stool frequency of <1 stool every 7 days or more than 3 stools per week.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Orafti® Inulin

Experimental group

Description:

Daily consumption of 12g Orafti® Inulin (3x 4g/d) over a period of 4 weeks

Treatment:

Dietary Supplement: Orafti® Inulin

Placebo

Placebo Comparator group

Description:

Daily consumption of 12g/ Maltodextrin (3x 4g/d) over a period of 4 weeks

Treatment:

Dietary Supplement: Placebo