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

Zhejiang University

Status

Withdrawn

Conditions

Chemotherapy-related Diarrhea

Treatments

Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule

Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT04447443

2019-111

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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