Study of beneficial effect of Bio Sun Kids sachets in children with loose stools

Phase 4

Not yet recruiting

Conditions: Diseases of the digestive system,

Registration Number: CTRI/2023/08/056064

Lead Sponsor: Tablets India

Brief Summary: **AIM:**To investigate the efficacy of BioSun Kids in the management of diarrhea in infants and children.

**PRIMARY OBJECTIVE**: To evaluate the efficacy and safety of BioSun Kids on reducing the episodes(frequency) and duration and diarrhea induced by rotavirus.

**STUDY DESIGN:** Double-blind, randomised, placebo controlled, prospective treatment study.

**PLACE OF STUDY:**Chettinad Hospital and research institute

**SAMPLE SIZE CALCULATION:**A sample size of the convenience of 100 infants/children, age 3 month to 5 years.

**STUDY GROUPS:**

**1. Study group:** Group A: ORS + Zinc + Probiotic sachet (Bio Sun Kids) constituting Bacillus mesentericus T-OA -1 Million Lactobacillus sporogenes - 50 Million, Streptococcus Thermophilus St-21- 100 Million, Bacillus Clausii - 2 Billion will be given -  twice a day after mixing in 10 ml of water for 1 week.

**2. Control group:** Group B: ORS + Zinc + placebo mixed in 10 ml of water for 1 week.

**STUDY INTERVENTION:**BioSun Kids sachet which contains probiotic sachet constituting Bacillus mesentericus T-OA -1 Million Lactobacillus sporogenes - 50 Million, Streptococcus Thermophilus St-21- 100 Million, Bacillus Clausii - 2 Billion.

**INCLUSION CRITERIA:**

1. Children of either sex aged 3months to 5 years suffering from acute diarrhea of rotaviral origin (duration < 3 days)

2. Children with the above symptoms and those excreting stool positive for rotavirus.

**EXCLUSION CRITERIA:**

1. Patients with infectious diarrhea other than rotaviral diarrhea.

2. Patients with serum sodium concentration above 155 or below 130 mmol/L.

3. Those with history of malabsorption syndromes.

4. Having respiratory infections / systemic infection.

**METHODOLOGY:**

1. All patients will be treated with WHO criteria ORS for no and some dehydration or intravenous fluid if needed, till the resolution of diarrhea and zinc 20 mg/day for 7 days.

2. Apart from this standard treatment, study group will be given probiotic (BioSun Kids) sachet twice a day after mixing in 10 ml of water for 7 days

3. The control group will be given only standard treatment of diarrhea and placebo mixed in 10 ml of water for 7 days

**DOSE RECOMMENDATIONS:** BioSun Kids or placebo will be given in the form of â€˜sachetsâ€™ in addition to rehydration therapy at a dose of 1 sachet two times daily up to 7 days.

**AGE GROUP:**  3 months to 5 years

**FOLLOW UP**: post 7 days of treatment completion.

**STUDY DURATION:**  7 days

**OUTCOME:** Study group arm anticipated to show clinical as well as statistically significant reduction in the following

1. Number of episodes (frequency) of diarrhea in a day

2. Mean duration of diarrhoea (in days)

3. Degree of dehydration

4. Duration and volume of oral rehydration salt [ORS] therapy

5. Duration and volume of intravenous fluid [IVF] therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Children of either sex aged 3months to 5 years suffering from acute diarrhea of rotaviral origin (duration < 3 days) 1.
Children with the above symptoms and those excreting stool positive for rotavirus.

Exclusion Criteria

Patients with infectious diarrhea other than rotaviral diarrhea.
Patients with serum sodium concentration above 155 or below 130 mmol/L.
Those with history of malabsorption syndromes.
Having respiratory infections / systemic infection.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study group arm anticipated to show clinical as well as statistically significant reduction in the following â€“	7 days
1.Number of episodes (frequency) of diarrhea in a day	7 days
2.Mean duration of diarrhoea (in days)	7 days
3.Degree of dehydration	7 days
4.Duration & volume of oral rehydration salt [ORS] therapy	7 days
5.Duration & volume of intravenous fluid [IVF] therapy.	7 days

Secondary Outcome Measures

Name	Time	Method
1. Duration & volume of intravenous fluid [IVF] therapy.	7 days

Trial Locations

Locations (1): Chettinad hospital and research institute
🇮🇳
Chennai, TAMIL NADU, India
Chettinad hospital and research institute
🇮🇳Chennai, TAMIL NADU, India
Dr S Siva Sankar
Principal investigator
8754707267
drsiva93@gmail.com