Oral ranitidine is effective in treating toddler's diarrhea

ISRCTN ISRCTN10783996
DOI https://doi.org/10.1186/ISRCTN10783996
Secondary identifying numbers CTS/16/01
Submission date
04/08/2016
Registration date
09/08/2016
Last edited
13/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Toddler’s diarrhea or chronic non-specific diarrhea of childhood is a common cause of persistent loose stools in children under-five. It has been defined as diarrhea lasting more than 3 weeks in a toddler who has normal weight and height, without being caused by a tummy bug (viral infection). Low-fat diets and the consumption of fruit juices, especially juices high in sorbitol (a type of sweetener) and those with high fructose (fruit sugar) are thought to play a role in this. Changing the diet and reducing the amount the child drinks have been suggested as potential treatments. Other studies have shown that some probiotics (so called ‘good’ bacteria) may also be effective in reducing symptoms. It has been noted however that following a strict diet can be difficult and so a safe medication treatment may be easier. Ranitidine is a medication which is used to lower the amount of acid produced by the stomach. The aim of this study is to investigate the effectiveness of ranitidine and probiotics in the treatment of Toddler’s diarrhea.

Who can participate?
Children aged 1-3 years who have had diarrhea for at least three weeks which is not caused by an infection.

What does the study involve?
Participants are randomly allocated to one of three groups. Children in the first group are given ranitidine by their caregiver once a day for 10 days in the form of dissolvable tablets. Children in the second group are given probiotics by their caregiver once a day for 10 days in the form of a powder that can be made into a liquid solution. Children in the third group are given a placebo (dummy), which consists of vitamin C, by their caregiver once a day for 10 days in the form of dissolvable tablets. For all groups, care-givers of participating children are asked to record the frequency and consistency of the child’s stool after 5, 10 and 30 days.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
1. University of Nigeria Teaching Hospital (Nigeria)
2. Enugu State University Teaching Hospital (Nigeria)
3. Federal Medical Centre (Nigeria)

When is the study starting and how long is it expected to run for?
May 2016 to October 2019

Who is funding the study?
African Research League (USA)

Who is the main contact?
1. Dr Samuel Uwaezuoke (scientific)
2. Dr Ikenna Ndu (public)

Contact information

Dr Samuel Uwaezuoke
Scientific

Department of Paediatrics
University of Nigeria Teaching Hospital
Ituku-Ozalla
Enugu
400001
Nigeria

ORCiD logoORCID ID 0000-0002-2464-6645
Dr Ikenna Ndu
Public

Department of Paediatrics
Enugu State University Teaching Hospital
Enugu
400001
Nigeria

Study information

Study designMulti-centre double-blind three-arm randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleShort 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
Study objectivesRanitidine is more effective than probiotics in the treatment of toddler's diarrhea.
Ethics approval(s)University of Nigeria Teaching Hospital Health Research Ethics Committee, 19/05/2016, ref: NHREC/05/01/2008B-FW00002458-1RB00002323
Health condition(s) or problem(s) studiedToddler's diarrhea (chronic non-specific diarrhea of childhood)
InterventionParticipants 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.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)1. Ranitidine 2. Lyophilized lactic acid bacteria
Primary outcome measure1. 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 measuresNo secondary outcome measures
Overall study start date02/05/2016
Completion date30/10/2019

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit3 Years
SexBoth
Target number of participants120
Total final enrolment40
Key inclusion criteria1. 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
Key exclusion criteria1. Signs of dehydration
2. Presence of pyrexia
3. Abnormal anthropometry
Date of first enrolment30/07/2016
Date of final enrolment01/03/2019

Locations

Countries of recruitment

  • Nigeria

Study participating centres

University of Nigeria Teaching Hospital
Ituku-Ozalla
Enugu
400001
Nigeria
Enugu State University Teaching Hospital
Enugu
400001
Nigeria
Federal Medical Centre
Owerri
400001
Nigeria

Sponsor information

African Research League
Research organisation

694 Salisbury Street
Worcester
01609
United States of America

Website https://www.linkedin.com/groups/8467425

Funders

Funder type

Research organisation

African Research League

No information available

Results and Publications

Intention to publish date30/10/2020
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planTo publish results in a reputable journal once data analysis and manuscript write up is completed.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 31/07/2019 31/07/2019 No No
Basic results 09/09/2019 09/09/2019 No No
Results article results 11/08/2020 14/08/2020 Yes No
Protocol file 10/10/2022 No No
Other files Brief curriculum vitae of co-investigator (AdaAyuk) 13/10/2022 No No

Additional files

ISRCTN10783996_BasicResults_31Jul2019.pdf
Uploaded 31/07/2019
ISRCTN10783996_BasicResults_09Sept19.pdf
Uploaded 09/09/2019
32428 PROTOCOL.pdf
32428 Brief curriculum vitae of co-investigator (AdaAyuk).pdf
Brief curriculum vitae of co-investigator (AdaAyuk)

Editorial Notes

13/10/2022: An additional file was uploaded.
10/10/2022: Uploaded protocol (not peer-reviewed) as an additional file.
14/08/2020: Publication reference added.
09/09/2019: The updated basic results of this trial have been uploaded as an additional file.
31/07/2019: The basic results of this trial have been uploaded as an additional file. The total final enrolment number was corrected from 30 to 40.
10/04/2019: IPD sharing statement added.
09/04/2019: The following changes were made to the trial record:
1. The total final enrolment number was added.
2. The overall trial end date was changed from 31/03/2019 to 30/10/2019.
3. The intention to publish date was changed from 31/08/2019 to 30/10/2020.
27/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2016 to 01/03/2019.
2. The overall trial end date was changed from 30/10/2016 to 31/03/2019.
3. The intention to publish date was changed from 31/03/2017 to 31/08/2019.
4. The plain English summary was updated.