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
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
Scientific
Department of Paediatrics
University of Nigeria Teaching Hospital
Ituku-Ozalla
Enugu
400001
Nigeria
 ORCID ID |
0000-0002-2464-6645 |
|---|
Public
Department of Paediatrics
Enugu State University Teaching Hospital
Enugu
400001
Nigeria
Study information
| Study design | Multi-centre double-blind three-arm randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | Ranitidine 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 1. Ranitidine 2. Lyophilized lactic acid bacteria |
| Primary outcome measure | 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 study start date | 02/05/2016 |
| Completion date | 30/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 3 Years |
| Sex | Both |
| Target number of participants | 120 |
| Total final enrolment | 40 |
| Key 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 |
| Key exclusion criteria | 1. Signs of dehydration 2. Presence of pyrexia 3. Abnormal anthropometry |
| Date of first enrolment | 30/07/2016 |
| Date of final enrolment | 01/03/2019 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
Enugu
400001
Nigeria
400001
Nigeria
400001
Nigeria
Sponsor information
Research organisation
694 Salisbury Street
Worcester
01609
United States of America
| Website | https://www.linkedin.com/groups/8467425 |
|---|
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 30/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | To publish results in a reputable journal once data analysis and manuscript write up is completed. |
| IPD sharing plan | The 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.
