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Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors

NCT04447443 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-08-06

No results posted yet for this study

Summary

This study evaluates longitudinal data associating changes in gut microbiota composition and diversity, defecation, performance status and adverse reactions in response to prebiotic fiber supplementation in patients with gastrointestinal cancer chemotherapy-related diarrhea. 120 adult participants , age 18 to 65 years, will be randomized into one of the two arms. Arm A (intervention group) will receive prebiotic fiber and loperamide hydrochloride capsule(a drug for standard treatment). Arm B will receive maltodextrin placebo and loperamide hydrochloride capsule.

Conditions

  • Chemotherapy-related Diarrhea

Interventions

DIETARY_SUPPLEMENT

Prebiotic Fiber Supplement + loperamide hydrochloride capsule

2-week sequential supplementation with prebiotic fiber supplement (3.5g, twice a day). The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.

DIETARY_SUPPLEMENT

Maltodextrin + loperamide hydrochloride capsule

2-week sequential supplementation with placebo of of maltodextrin (3.5g, twice a day). The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER

  • Jinhua Municipal Central Hospital

    collaborator OTHER

  • Quzhou Kecheng People's Hospital

    collaborator UNKNOWN

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Pianhong Zhang · Second Affiliated Hospital, Zhejiang University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • China

Study Locations

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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 NCT04447443 on ClinicalTrials.gov