Diarrhea, InfantileNCT00732732
A Controlled Trial of Plantain Powder in Infantile Diarrhea
A study testing Green banana powder and Microcrystalline cellulose in people with Diarrhea, Infantile, run by Augusta University at 1 site in India.
Trial summary
Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea. The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea. Read more about this study
- Who is it for?
- Ages 5 to 24 months
- Conditions the study is for
- Diarrhea, Infantile
- What is being tested?
- Green banana powder and Microcrystalline cellulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2008to Jan 2010
- 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 5 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital.
- Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject
- The consistency of the stool is such that it takes the shape of the container into which it is put in.
- Duration of symptoms should be less than 14 days.
- -
Who cannot join
- Children with bloody diarrhea
- Children with lethargy, fever or other signs of septicemia
- Children with shock.
- Children unable to take medications orally.
- Children with impaired consciousness.
- Children whose parents refuse permission to be included in the study.
Show all 9Show fewer
- Children who are not usual residents of the area and will not be available for follow up.
- Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea.
The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea.
Infants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study).
Two hundred patients will be enrolled in 24 months.
- Conditions
- Diarrhea, Infantile
- Being tested
- Green banana powder, Microcrystalline cellulose
- Keywords
- diarrhea, Plantain, Green banana, Infants, Children
- Medical subject headings
- Diarrhea, Infantile, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green banana powderDietary supplement
Green banana in powder form, 10 grams/ day for children below 10 kg, 20 grams for those weighing 10 Kg or more. Protocol Modified on Aug 5th 2009 to give 20 grams irrespective of age.
Microcrystalline celluloseOther
Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more
| Study group | Role | What they receive |
|---|---|---|
| Green banana | Experimental | Subjects receiving green banana powder. Receives: Dietary Supplement: Green banana powder |
| Placebo | Placebo comparator | Microcrystalline cellulose given as placebo Receives: Other: Microcrystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of stools per day.
Measured: Daily for 10 days
Secondary outcomes (1)
Change in the consistency of stool.
Measured: Daily for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diarrhea, InfantileStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- NRS Medical College, Kolkata, West Bengal, India, School of Tropical Medicine, Kolkata, West Bengal, India
- Investigators
- Tapas K Sabui, MD, Principal investigator, NRS Medical College, Kolkata.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732732
- Sponsor's protocol ID
- HAC 08-01-165
- Status last verified
- Aug 2011
- First submitted
- 8 Aug 2008
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rabbani GH, Teka T, Saha SK, Zaman B, Majid N, Khatun M, Wahed MA, Fuchs GJ. Green banana and pectin improve small intestinal permeability and reduce fluid loss in Bangladeshi children with persistent diarrhea. Dig Dis Sci. 2004 Mar;49(3):475-84. doi: 10.1023/b:ddas.0000020507.25910.cf.
PubMed 15139502Rabbani GH, Teka T, Zaman B, Majid N, Khatun M, Fuchs GJ. Clinical studies in persistent diarrhea: dietary management with green banana or pectin in Bangladeshi children. Gastroenterology. 2001 Sep;121(3):554-60. doi: 10.1053/gast.2001.27178.
PubMed 11522739
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
- ClinicalTrials.gov ID
- NCT00732732
- Acronym / sponsor ID
- HAC 08-01-165
- Conditions
- Diarrhea, Infantile
- Keywords
- diarrhea, Plantain, Green banana, Infants, Children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- NRS Medical College, Kolkata, West Bengal, India, School of Tropical Medicine, Kolkata, West Bengal, India
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 12 Aug 2008 (estimated)
- 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.
Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea.
The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea.
Infants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study).
Two hundred patients will be enrolled in 24 months.
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 |
|---|---|---|
| Green banana | Experimental | Dietary Supplement: Green banana powderSubjects receiving green banana powder. |
| Placebo | Placebo comparator | Other: Microcrystalline celluloseMicrocrystalline cellulose given as placebo |
Who may qualify
- Ages
- 5 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital.
- Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject
- The consistency of the stool is such that it takes the shape of the container into which it is put in.
- Duration of symptoms should be less than 14 days.
- -
Key exclusion criteria (9 listed)
- Children with bloody diarrhea
- Children with lethargy, fever or other signs of septicemia
- Children with shock.
- Children unable to take medications orally.
- Children with impaired consciousness.
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 |
|---|---|---|
| Green banana powderGreen banana in powder form, 10 grams/ day for children below 10 kg, 20 grams for those weighing 10 Kg or more. Protocol Modified on Aug 5th 2009 to give 20 grams irrespective of age. | Dietary supplement | Green banana |
| Microcrystalline celluloseMicrocrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more | Other | Placebo |
Primary outcome
Frequency of stools per day.
Time frame: Daily for 10 days
1 secondary outcome
Change in the consistency of stool.
Time frame: Daily for 10 days
Results and safety
The study was stopped early (reason given: Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Results publication: PubMed 15139502Rabbani GH, Teka T, Saha SK, Zaman B, Majid N, Khatun M, Wahed MA, Fuchs GJ. Green banana and pectin improve small intestinal permeability and reduce fluid loss in Bangladeshi children with persistent diarrhea. Dig Dis Sci. 2004 Mar;49(3):475-84. doi: 10.1023/b:ddas.0000020507.25910.cf.
- Results publication: PubMed 11522739Rabbani GH, Teka T, Zaman B, Majid N, Khatun M, Fuchs GJ. Clinical studies in persistent diarrhea: dietary management with green banana or pectin in Bangladeshi children. Gastroenterology. 2001 Sep;121(3):554-60. doi: 10.1053/gast.2001.27178.
Related trials for Diarrhea, Infantile
Recruiting
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Infantile Colics, Constipation
Recruiting
Whole Genome Sequencing Versus Whole Exome Sequencing for Congenital Diarrhea and Enteropahty
Diarrhea, Infantile, Enteropathy
RecruitingPhase 1/2
Fortified Oral Rehydration Therapy for Pediatric Diarrhea
Acute Gastroenteritis
Recruiting
BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
Infantile Colic, Gastroesophageal Reflux (GER)
RecruitingObservational study
Phenotype and Multi-omics Analysis of Children With Congenital Diarrhea and Enteropathy in China
Diarrhea Infantile
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.
Tapas K Sabui, MD principal investigator
NRS Medical College, Kolkata.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green banana powder and Microcrystalline cellulose in people with Diarrhea, Infantile, run by Augusta University at 1 site in India.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 8 Aug 2011. 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 India. 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 stopped early (reason given: Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.). Results are not available in the source record.
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?
Frequency of stools per day. (time frame: Daily for 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00732732, which also lists 2 linked publications.
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 8 Aug 2011.