Condition category
Digestive System
Date applied
04/08/2016
Date assigned
09/08/2016
Last edited
08/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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 2016

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

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Samuel Uwaezuoke

ORCID ID

http://orcid.org/0000-0002-2464-6645

Contact details

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

Type

Public

Additional contact

Dr Ikenna Ndu

ORCID ID

Contact details

Department of Paediatrics
Enugu State University Teaching Hospital
Enugu
400001
Nigeria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CTS/16/01

Study information

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

Acronym

Study hypothesis

Ranitidine is more effective than probiotics in the treatment of toddler's diarrhea.

Ethics approval

University of Nigeria Teaching Hospital Health Research Ethics Committee, 19/05/2016, ref: NHREC/05/01/2008B-FW00002458-1RB00002323

Study design

Multi-centre double-blind three-arm randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Toddler's diarrhea (chronic non-specific diarrhea of childhood)

Intervention

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

1. Ranitidine
2. Lyophilized lactic acid bacteria

Primary outcome measures

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 measures

No secondary outcome measures

Overall trial start date

02/05/2016

Overall trial end date

30/10/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Signs of dehydration
2. Presence of pyrexia
3. Abnormal anthropometry

Recruitment start date

30/07/2016

Recruitment end date

30/09/2016

Locations

Countries of recruitment

Nigeria

Trial participating centre

University of Nigeria Teaching Hospital
Ituku-Ozalla
Enugu
400001
Nigeria

Trial participating centre

Enugu State University Teaching Hospital
Enugu
400001
Nigeria

Trial participating centre

Federal Medical Centre
Owerri
400001
Nigeria

Sponsor information

Organisation

African Research League

Sponsor details

694 Salisbury Street
Worcester
01609
United States of America

Sponsor type

Research organisation

Website

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

Funders

Funder type

Research organisation

Funder name

African Research League

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To publish results in a reputable journal once data analysis and manuscript write up is completed- to prove that oral ranitidine may be effective in the treatment of toddler's diarrhea.

Intention to publish date

31/03/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes