NCT04447443

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

August 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

June 17, 2020

Last Update Submit

August 1, 2021

Conditions

Chemotherapy-related Diarrhea

Outcome Measures

Primary Outcomes (1)

  • Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea

    Numbers of bowel movements per day

    2 weeks

Secondary Outcomes (4)

  • onset time

    2 weeks

  • Adverse events

    2 weeks

  • Changs in Karnofsky Performance Status

    2 weeks

  • Gut microbiota changes in response to intervention

    Change from baseline in gut microbiota at 1 and 2 weeks ]

Study Arms (2)

Prebiotic Fiber

EXPERIMENTAL
Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule

Maltodextrin

PLACEBO COMPARATOR
Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule

Interventions

Prebiotic Fiber Supplement + loperamide hydrochloride capsuleDIETARY_SUPPLEMENT

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.

Prebiotic Fiber
Maltodextrin + loperamide hydrochloride capsuleDIETARY_SUPPLEMENT

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.

Maltodextrin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Interventions

Loperamidemaltodextrin

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pianhong Zhang

    Second Affiliated Hospital, Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

June 25, 2020

Study Start

June 30, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

August 6, 2021

Record last verified: 2021-07

Locations

CN(1)