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

Not Applicable

Withdrawn

• Conditions: Chemotherapy-related Diarrhea
• Interventions: Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule; Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule

• Registration Number: NCT04447443
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-25
• Study Start: 2020-06-30
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-08-01
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18-65, be able to comply with the protocol
• Life expectancy greater than 3 months
• Patients with cytologically or histologically confirmed diagnosis of gastrointestinal cancers
• Undergoing chemotherapy, not synchronized with radiotherapy and other anti-tumor treatments
• Chemotherapy-related diarrhea grade 2-4
• Not experience diarrhea before chemotherapy

Exclusion Criteria

• age<18 or >65
• Patients who cannot eat by mouth for example chewing disorders, difficulty swallowing, intractable vomiting, gastrointestinal obstruction or gastrointestinal tract bleeding
• Other acute or chronic diarrhea or colostomy
• Patients with other severe adverse effects of chemotherapy other than diarrhea
• Patients with severe diseases of heart, kidney, liver and other major organs
• Use of any other drug for promoting intestine movement
• Use of any other drug or dietary supplement for chemotherapy-related diarrhea such as other fiber supplements, probiotics, octreotide
• Allergic to the components of the intervention dietary supplements;
• Pregnancy (positive serum pregnancy test) and lactation
• Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prebiotic Fiber	Prebiotic Fiber Supplement + loperamide hydrochloride capsule	-
Maltodextrin	Maltodextrin + loperamide hydrochloride capsule	-

Primary Outcome Measures

Name	Time	Method
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea	2 weeks	Numbers of bowel movements per day

Secondary Outcome Measures

Name	Time	Method
Changs in Karnofsky Performance Status	2 weeks
onset time	2 weeks
Gut microbiota changes in response to intervention	Change from baseline in gut microbiota at 1 and 2 weeks ]	16S rRNA sequencing
Adverse events	2 weeks	Incidence of mild (e.g. self-resolving), moderate (e.g. those that warrant medical evaluation and treatment) and serious (e.g. those that cannot be resolved by medical treatment) adverse events based on criteria adopted by the National Institute of Health common terminology criteria for adverse events (NIH severity) will be evaluated

Trial Locations

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China