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

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.

Study Overview

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Maltodextrin

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.

Experimental: Prebiotic Fiber

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Time Frame: 2 weeks
Numbers of bowel movements per day
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
onset time
Time Frame: 2 weeks
2 weeks
Adverse events
Time Frame: 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
2 weeks
Changs in Karnofsky Performance Status
Time Frame: 2 weeks
2 weeks
Gut microbiota changes in response to intervention
Time Frame: Change from baseline in gut microbiota at 1 and 2 weeks ]
16S rRNA sequencing
Change from baseline in gut microbiota at 1 and 2 weeks ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 30, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

June 17, 2020

First Submitted That Met QC Criteria

June 23, 2020

First Posted (Actual)

June 25, 2020

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 1, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy-related Diarrhea

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