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

Beneo GmbH54 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Constipation

Interventions

Orafti® InulinDIETARY_SUPPLEMENT

Dietary fiber

PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

BioTeSys GmbH

Esslingen am Neckar, Germany

Outcomes

Primary Outcomes

Stool frequency determined by daily questionnaire

Stool frequency determined by daily questionnaire.

Time frame: 4 weeks

Secondary Outcomes

Stool consistency rated according to the Bristol Stool Form Scale

Stool consistency rated according to the Bristol Stool Form Scale from Type 1 to Type 7.

Time frame: 4 weeks

Questionnaire on Gastrointestinal characteristics

Sensation of straining, abdominal discomfort, bloating/distension, passage of gas and feeling of incomplete emptying rated on a 5-point scale (0 = not at all, 1 = very slightly, 2 = slightly, 3 = moderately, 4 = extremely).

Time frame: 4 weeks

Questionnaire on Participant Assessment of Constipation Quality of Life (PAC-QoL)

Severity of each symptom rated on a five-point scale from 0 (not at all / none of the time) to 4 (extremely / all of the time).

Time frame: 4 weeks

Faecal microbiota composition determined by illumina sequencing

Determined by illumina sequencing.

Time frame: 4 weeks

Stool metabolite profiling determined by GC/LC-MS

Determined by GC/LC-MS.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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