NCT05213494

The Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children

A Randomized, Controlled, Crossover Study to Assess the Effects of Soluble Corn Fiber on Gastrointestinal Tolerance and Fecal Microbiome in Healthy Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Tate & Lyle · Industry
• Sex: All
• Age: 3 Years – 9 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at levels that could contribute to closing the fiber gap. The dose response effects of PROMITOR® Soluble Corn Fiber in healthy children will also be compared.

Detailed description

After initial site visits and randomization children were given a packet of powdered fiber to be mixed into a beverage daily. There were four test arms, described elsewhere. Each study arm lasted 10 days with an 18 day washout in between study periods.

Conditions

• Gastrointestinal Tolerance

Interventions

Type	Name	Description
OTHER	Inulin	Inulin, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.
OTHER	soluble corn fiber	soluble corn fiber, a dietary fiber, will be given in a beverage daily in doses 3g, 5g, 6g, or 8g dependent on arm and age of participants.

Timeline

• Start date: 2021-05-20
• Primary completion: 2021-10-28
• Completion: 2021-10-28
• First posted: 2022-01-28
• Last updated: 2022-01-28

Locations

1 site across 1 country: United States