- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04447443
Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
Study Overview
Status
Conditions
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310009
- Second Affiliated Hospital, Zhejiang University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Investigators
- Principal Investigator: Pianhong Zhang, Second Affiliated Hospital, Zhejiang University School of Medicine
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-111
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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