Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults with Constipation

Not Applicable

Completed

• Conditions: Constipation - Functional
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: PHGG

• Registration Number: NCT04587635
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially Hydrolyzed Guar Gum (PHGG) in Adults with Constipation

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-09-24
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Primary Completion: 2021-11-05
• Study Completion: 2021-11-05
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Maltodextrin	Placebo	Maltodextrin
PHGG fiber	PHGG	PHGG Fiber

Primary Outcome Measures

Name	Time	Method
SBM	Baseline to end of treatment, up to 6 weeks.	Change in mean frequency of Spontaneous Bowel Movements (SBM) as measured by the daily bowel diary from baseline to Week 6 in the treatment group compared to placebo. Frequency will be defined as the mean number of SBM for the 2-week run-in period prior to V0 and the final 2-week period of the intervention period.

Trial Locations

Locations (1)

Atlantia Food Clinical Trial; 🇮🇪 Cork, Ireland