Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
NCT ID: NCT04447443
Last Updated: 2021-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2020-06-30
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Prebiotic Fiber
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.
Maltodextrin
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang Cancer Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Jinhua Municipal Central Hospital
OTHER
Quzhou Kecheng People's Hospital
UNKNOWN
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Pianhong Zhang
Role: PRINCIPAL_INVESTIGATOR
Second Affiliated Hospital, Zhejiang University School of Medicine
Locations
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Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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2019-111
Identifier Type: -
Identifier Source: org_study_id
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