Chemotherapy-related DiarrheaNCT04447443
Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
A study testing Prebiotic Fiber Supplement + loperamide hydrochloride capsule and Maltodextrin + loperamide hydrochloride capsule in people with Chemotherapy-related Diarrhea, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy-related Diarrhea
- What is being tested?
- Prebiotic Fiber Supplement + loperamide hydrochloride capsule and Maltodextrin + loperamide hydrochloride capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
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.
- Conditions
- Chemotherapy-related Diarrhea
- Being tested
- Prebiotic Fiber Supplement + loperamide hydrochloride capsule, Maltodextrin + loperamide hydrochloride capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic Fiber | Experimental | Not described Receives: Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule |
| Maltodextrin | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Numbers of bowel movements per day
Measured: 2 weeks
Secondary outcomes (4)
onset time
Measured: 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
Measured: 2 weeks
Changs in Karnofsky Performance Status
Measured: 2 weeks
Gut microbiota changes in response to intervention
16S rRNA sequencing
Measured: Change from baseline in gut microbiota at 1 and 2 weeks ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: discontinued prematurely by sponsor for strategic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-related DiarrheaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital
- Responsible party
- Sponsor
- Investigators
- Pianhong Zhang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447443
- Sponsor's protocol ID
- 2019-111
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2020
- Last updated
- 6 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Dietary Fiber as Prebiotics on Chemotherapy-related Diarrhea in Patients With Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT04447443
- Acronym / sponsor ID
- 2019-111
- Conditions
- Chemotherapy-related Diarrhea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: discontinued prematurely by sponsor for strategic reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Cancer Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Jinhua Municipal Central Hospital, Quzhou Kecheng People's Hospital
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic Fiber | Experimental | Dietary Supplement: Prebiotic Fiber Supplement + loperamide hydrochloride capsule |
| Maltodextrin | Placebo comparator | Dietary Supplement: Maltodextrin + loperamide hydrochloride capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic Fiber Supplement + loperamide hydrochloride capsule2-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. | Dietary supplement | Prebiotic Fiber |
| Maltodextrin + loperamide hydrochloride capsule2-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. | Dietary supplement | Maltodextrin |
Primary outcome
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea
Time frame: 2 weeks
Numbers of bowel movements per day
4 secondary outcomes
onset time
Time frame: 2 weeks
Adverse events
Time frame: 2 weeks
Changs in Karnofsky Performance Status
Time frame: 2 weeks
Gut microbiota changes in response to intervention
Time frame: Change from baseline in gut microbiota at 1 and 2 weeks ]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pianhong Zhang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic Fiber Supplement + loperamide hydrochloride capsule and Maltodextrin + loperamide hydrochloride capsule in people with Chemotherapy-related Diarrhea, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic effect on the chemotherapy-related grade 2 to 4 diarrhea (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.