Fiber Nutritional Supplement for Management of Constipation During Pregnancy

This study aims to evaluate the effectiveness of a daily Fiber Nutritional Supplement (Materna® Opti fiber), containing partially hydrolyzed guar gum (PHGG) and vitamins C, D, zinc, and selenium, combined with nutritional counselling, for the management of constipation during pregnancy. Constipation is a common gastrointestinal complaint in pregnancy and may negatively affect quality of life and well being. The study is designed as an open label, single arm intervention conducted in pregnant women between 13 and 27 weeks of gestation who meet the Cullen 2007 criteria for functional constipation. A total of 31 participants are planned for enrolment. Eligible participants will receive one sachet per day of the Fiber Nutritional Supplement (Materna® Opti fiber), providing approximately 5.8 g of PHGG, for a duration of 4 weeks. In addition to the investigational product, all participants will receive standardized constipation counselling at baseline, including education on constipation, lifestyle measures.

NCT Number	NCT07588633
Lead Sponsor	Société des Produits Nestlé (SPN)
Conditions	Functional Constipation (FC)
Enrollment	31 participants
Start Date	2026-05-08
Primary Completion	2026-08-08 (estimated)
Study Completion	2026-10-08 (estimated)
Updated on ClinicalTrials.gov	2026-05-15