Prebiotic Fructans Effect on 1-3 Years Constipated Children's Bowel Habits

NCT03941925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-07-12

No results posted yet for this study

Summary

The aim of the study is to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on bowel function in young children.

Conditions

Interventions

DIETARY_SUPPLEMENT

Prebiotic fructans

Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.

DIETARY_SUPPLEMENT

Non-prebiotic maltodextrin

Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.

Sponsors & Collaborators

  • Beneo GmbH

    collaborator INDUSTRY
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Wei Cai, Doctor · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • Weihui Yan, Doctor · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • Ying Wang, Doctor · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • Lina Lu, Doctor · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • YIjing Tao · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • Haixia Feng · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • Yinghong Chen · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

  • Anna Li · Xin Hua Hospital,School of Medicine, Shanghai Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03941925 on ClinicalTrials.gov