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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chemotherapy-related Diarrhea

Intervention / Treatment
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* Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule
* Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prebiotic Fiber<br> | Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule<br>* 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.<br>|
| Placebo Comparator: Maltodextrin<br> | Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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