|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
24 October 2022 |
|
Main ID: |
ISRCTN10783996 |
|
Date of registration:
|
09/08/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Oral ranitidine is effective in treating toddler's diarrhea
|
|
Scientific title:
|
Short course of daily oral ranitidine versus probiotics as a novel effective treatment for toddler's diarrhea: a multi-centre, double-blind randomized controlled clinical trial |
|
Date of first enrolment:
|
30/07/2016 |
|
Target sample size:
|
120 |
|
Recruitment status: |
Completed |
|
URL:
|
https://www.isrctn.com/ISRCTN10783996 |
|
Study type:
|
Interventional |
|
Study design:
|
Multi-centre double-blind three-arm randomized controlled trial (Treatment)
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Nigeria
| | | | | | | |
|
Contacts
|
|
Name:
|
Ikenna
Ndu |
|
Address:
|
Department of Paediatrics
Enugu State University Teaching Hospital
400001
Enugu
Nigeria |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Samuel
Uwaezuoke |
|
Address:
|
Department of Paediatrics
University of Nigeria Teaching Hospital
Ituku-Ozalla
400001
Enugu
Nigeria |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Age range of 1-3 years
2. Diarrhea lasting 3 weeks or more
3. Characteristic stooling pattern of toddler's diarrhea
4. Absence of pyrexia and signs of dehydration
5. Normal anthropometry
6. Normal findings on stool analysis, microscopy and culture
Exclusion criteria:
1. Signs of dehydration
2. Presence of pyrexia
3. Abnormal anthropometry
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Toddler's diarrhea (chronic non-specific diarrhea of childhood)
Digestive System
Toddler's diarrhea (chronic non-specific diarrhea of childhood)
|
|
Intervention(s)
|
Participants are randomised to one of three groups, using colour-coded envelopes.
Ranitidine Group: Participants receive dissolvable tablets of ranitidine (3 mg/kg/day), administered daily by caregivers for 10 days.
Probiotic Group: Participants receive probiotics in powdery form for solution, in age-specific doses, administered daily by caregivers for 10 days.
Control Group: Participants receive a placebo in the form of dissolvable tablets of vitamin C (50 mg) administered daily by caregivers for 10 days.
Follow-up/outcome measures: Stool frequency and consistency will be recorded on days 5 and 10. Any adverse drug reactions will be noted on these follow-up days. There will also be a follow-up documentation of stool frequency and consistency at 30 days.
|
|
Primary Outcome(s)
|
1. Stool frequency is measured using care-giver's home observation/records on days 5, 10 and 30
2. Stool consistency is measured using care-giver's home observation/records on days 5, 10 and 30
|
|
Secondary Outcome(s)
|
|
No secondary outcome measures
|
|
Secondary ID(s)
|
|
CTS/16/01
|
|
Source(s) of Monetary Support
|
|
African Research League
|
|
Ethics review
|
Status:
Approval date:
Contact:
University of Nigeria Teaching Hospital Health Research Ethics Committee, 19/05/2016, ref: NHREC/05/01/2008B-FW00002458-1RB00002323
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
30/10/2019 |
|
URL:
|
|
|
|