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Green Banana (GB) Mixed Diet in the Management of Persistent Diarrhea (PD)

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ClinicalTrials.gov Identifier: NCT03366740
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
Diarrhea is the 2nd leading cause of death in under-five children. When diarrhea continued for 14 days or more it is known as Persistent Diarrhea (PD). In low and middle income countries (LMIC), 3%-23% of acute diarrheal episodes turn to PD. PD causes 32-62% of all diarrheal deaths in LMIC, and >25% in Bangladesh in contrast to 0.8% is caused by acute diarrhea. The prevalence of PD varied from 6.3 to 16.4 %. However, no larger prospective study was conducted to evaluate the efficacy of green banana in the management of PD among children older than 6 months.An open-labeled randomized controlled clinical trial is designed to assess the efficacy of green banana mixed full strength rice suji, and full strength rice suji alone compared to 3/4th strength rice suji in the management of persistent diarrhea (PD) in children aged > 6 months to 36 months in the Dhaka Hospital of icddr,b.

Condition or disease Intervention/treatment Phase
Persistent Diarrhea Other: GB mixed full strength rice suji Other: Full strength rice suji Alone Other: 3/4th strength rice suji Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study design: This will be an open-labeled randomized controlled clinical trial with three treatment arms (3/4th strength rice suji, full strength rice suji with modification and GB mixed full strength rice suji). Investigators will prospectively screen, children > 6 to 36 months of age admitted to the Dhaka hospital of icddr,b, with PD or developed PD during their treatment period and failed to respond with milk suji and enroll them for the study. Thereafter permuted block randomization technique will be followed to select treatment arms for each child.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of GB Mixed Full Strength Rice Suji, and Full Strength Rice Suji Alone Compared to 3/4th Strength Rice Suji in the Management of PD in Children Aged > 6 Months to 36 Months: an Open-labeled Randomized Controlled Clinical Trial
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arm Intervention/treatment
Experimental: GB mixed full strength rice suji

On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn`t resolve, the child will be enrolled in the study and after randomization will get the GB mixed full strength rice suji.

The allocated diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.

Other: GB mixed full strength rice suji
On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn`t resolve, the child will be enrolled in the study and after randomization will get the Green banana mixed full strength rice suji The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.

Experimental: Full strength rice suji alone
On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn`t resolve, the child will be enrolled in the study and after randomization will get full strength rice suji alone.
Other: Full strength rice suji Alone

On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn`t resolve, the child will be enrolled in the study and after randomization will get full strength rice suji alone.

The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.


Active Comparator: 3/4th strength rice suji
On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn`t resolve, the child will be enrolled in the study and after randomization will get 3/4th strength rice suji.
Other: 3/4th strength rice suji

On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn`t resolve, the child will be enrolled in the study and after randomization will get 3/4th strength rice suji.

The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.





Primary Outcome Measures :
  1. By day 5, percentage of children recovered from diarrhea by the study diets [ Time Frame: 5 days ]
    Recovery from diarrhea is desired in PD.so, study outcome will be measured by calculating the percentage of children recovered from diarrhea by the study diets by day 5.


Secondary Outcome Measures :
  1. By day 7, percentage of children recovered from diarrhea by the study diets [ Time Frame: 7 days ]
    Recovery from diarrhea is desired in PD. So, one of the secondary outcome is to find the percentage of children recovered from diarrhea by the study diets by day 7.

  2. Frequency of stool in different days in different study diet groups [ Time Frame: 7 days ]
    One of the study outcome is to record frequency of bowel movement whether reduced or increased.

  3. Consistency of stool in different days in different study diet groups [ Time Frame: 7 days ]
    One of the study outcome is to record stool consistency whether soft or formed.

  4. Number of hospital acquired infection (HAI) in different study diet groups [ Time Frame: 7 days ]
    At hospital, children are at risk of getting HAI, the number of HAI with different diet will be recorded.

  5. Rate of relapse within 14 days follow up [ Time Frame: 14 days ]
    If a child`s PD resolved with study diet, the child will be discharged with the study diet. After discharge a child will be followed for 14 day with 2 follow up visit with the aim to identify the relapse rate.



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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aged > 6 to 36 months, having diarrhea for 14 days or more (up to 29 days) either at admission or developed at some point during their treatment period in hospital
  • Children able to take oral feeds at the time of randomization

Exclusion Criteria:

  • Children whose parents/care givers do not provide consent
  • Growth of Shigella, Salmonella or Cholera in rectal swab culture
  • Children having WLZ/WHZ < -5 SD or +++ edema
  • The children presented with septic shock, convulsion or any other illness that needs ICU support during the admission
  • Birth defect like complex congenital heart diseases, cleft lip and cleft palate, Down syndrome and cerebral palsy and others that may itself cause digestive problem or failing to thrive
  • Children diagnosed as having apparent or known tuberculosis or HIV or chronic (> 30 days)/organic diarrhea (where the cause is known e.g. crohn's disease, ulcerative colitis, celiac disease etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366740


Contacts
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Contact: Monira Sarmin, MBBS 01718596947 ext 2303 drmonira@icddrb.org
Contact: Md I Hossain, PhD 01711071075 ext 2351 ihossain@icdrb.org

Locations
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Bangladesh
Dhaka Hospital, icddr,b Recruiting
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Monira Sarmin, MBBS Medical officer, ICU

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03366740     History of Changes
Other Study ID Numbers: PR-17075
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Persistent diarrhea
> 6 to 36 months aged children
green banana
rice suji
milk suji
comminuted chicken
Additional relevant MeSH terms:
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Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms