Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children (GB in ProD)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-59
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

The study likely to yield improved therapeutic modalities for children with prolonged diarrhea, a sequalae often leads to persistent diarrhea, which is linked to as much as 35% of diarrhea-associated deaths in children \<5 years of age. If found effective, the therapy would led to early recovery, reduce duration of hospitalization, intercurrent hospital infection and overall expenditure related to this illness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: > 6 to 59 months

Sex: Either

Duration of diarrhea: 7 to 13 days

Children able to take oral feeds at the time of randomization

Disqualifiers

Children whose parents/care givers do not provide consent

Children presented with severe pneumonia, 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.

Children diagnosed as having apparent or known tuberculosis or HIV or PD (≥ 14 days)/organic diarrhea.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MS

    Drug

    Standard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml.

  • MS +GB

    Drug

    Investigators will use the food items including green banana (Musa paradisiacal sapientum). Unripe, whole GB fruit will be cooked in boiling water and 200 gram (wet weight) of it will be used to make a total 1000 ml milk suji. The control group will receive milk suji (without any added green banana);the standard practice of study site (Dhaka Hospital, icddr,b)

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: Milk sujiExperimental treatment 1 intervention
Group B: Arm MS +GBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

• Primary outcome: Clinical cure or Cessation of diarrhea

Clinical cure: \<3 liquid stools/24 hours after randomization Cessation of diarrhea: passage of soft/formed or no stool for consecutive two 8-hour periods

Time frame
Within 5 days from randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: