Bacillus coagulans MTCC 5856 in management of acute diarrhea in children

Recruiting

Brief Summary: At screening visit, demographics, vital signs, physical examination, medical and medication history will be done to assess the eligibility criteria by the Pediatrician.

The eligibility criteria will be verified. If the subject is found eligible, he/she will be randomized, and Investigational product will be dispensed to the parents or legal guardian to administer orally twice daily to the children. Stool sample will be collected for rotavirus and adenovirus screening. Children will be under observation of study team for six hours post 1st dose. Parents will be given subject diary and will be instructed to record diarrhea frequency and duration of diarrhea as well as investigational product compliance on daily basis. Information regarding the reporting of adverse events will be provided to the parents and will be instructed to visit site on day 3 and day 5. On day 3 and 5, vitals, physical examination, concomitant medication will be recorded. Duration and frequency of the diarrhea will be recorded in diary for all 5 days. Bristol stool chart will be assessed for all the episodes for all 5 days in a diary. Perceived efficacy scale of caregivers will be assessed on day 3 and day 5. Investigational product accountability will be done on day 5. The subject diary will be collected on day 5.

Recruitment & Eligibility

Inclusion Criteria

1.Children aged 1 to 10 years diagnosed with acute diarrhea.
2.Children who experienced more than 3 watery stools within last 24 hours.
3.Signed informed consent from one of the parents/legal guardians.
4.Children aged above 7 years willing to provide verbal assent will be counter signed by Parents.
5.Parentsâ€™/legal guardiansâ€™ willing to comply with all its procedures.

Exclusion Criteria

1.Subjects who require antibiotics treatment.
2.Subject who require intravenous fluid therapy.
3.Severe diarrhea which requires treatment other than ORS.
4.Severe dehydration as per WHO dehydration scale.
5.Immunodeficiency.
6.Malnourished (weight for height < 3 SD of WHO charts).
7.Surgery within one month prior to inclusion.
8.Children suffering from severe chronic illness.
9.Chronic pathologies (e.g.: cardiopathies, nephropathies, chronic gastrointestinal pathologies, endocrinopathies).
10.No consumption of commercial products containing probiotics including Yakult, during the study period.
11.Participation in any other clinical trial within 4 weeks prior to entry into the study.
12.Children Hospitalized for Pneumonia and acute gastroenteritis.
13.Children having bilious vomiting, hematochezia, pancreatic dysfunction or insufficiency judged by medical history.

Primary Outcome Measures

Name	Time	Method
a)Mean duration of diarrhea (expressed in hours), as counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score a score 5 is described as normalization of stool)	1 Day 3 & Day 5 \| 2 Day 3 & Day 5
b)Mean diarrhea frequency per day after initiation of treatment	1 Day 3 & Day 5 \| 2 Day 3 & Day 5

Secondary Outcome Measures

Name	Time	Method
a)Perceived efficacy among caregivers per perceived efficacy scale.	b)Dehydration status evaluated as per WHO classification.

Locations (3): Aarupadai Veedu medical College & Hospital
🇮🇳
Pondicherry, PONDICHERRY, India
Aditya Multi Speciality Hospital
🇮🇳
Guntur, ANDHRA PRADESH, India
Government Medical college & Government General Hospital (Old RIMSGGH)
🇮🇳
Srikakulam, ANDHRA PRADESH, India
Aarupadai Veedu medical College & Hospital
🇮🇳Pondicherry, PONDICHERRY, India
Dr A Thumjaa
Principal investigator
9841573725
thumjaa.annamalai@avmc.edu.in