Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Maltodextrin
Intervention: Maltodextrin + loperamide hydrochloride capsule (Dietary Supplement)
Prebiotic Fiber
Intervention: Prebiotic Fiber Supplement + loperamide hydrochloride capsule (Dietary Supplement)
Outcomes
Primary Outcomes
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Time Frame: 2 weeks
Numbers of bowel movements per day
Secondary Outcomes
- 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 ])
- Adverse events(2 weeks)