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What will be the efficacy of a Probiotic Curd for Childhood ARI

Efficacy and safety of probiotic curd supplementation in Acute Respiratory Infections (ARI) in children: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075469
Enrollment
120
Registered
2024-10-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00-J06- Acute upper respiratory infections

Interventions

Intervention1: 50ml probiotic curd daily for a period of 90 days : 50ml probiotic curd containing Lactobacillus bulgaricus (1 X 1010 CFU/ML), streptococcus thermophiles (1 X 1010 CFU/ML), and bifido b

Sponsors

(Expected) Department of Health Research, MoHFW, Govt of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children between 1year to 5 years and mothers who have given consent for the study. Pneumonia, according to the Control of Acute Respiratory Infection (CARI) Protocol of the World Health Organization (WHO) is defined as cough associated with tachypnea >40/min for 1-5 years old. May or may not be associated with chest indrawing or stridor (categorized as severe pneumonia). Who are residing in GHMC area.

Exclusion criteria

Exclusion criteria: Patients with congenital and other genetic co morbidities. Clinical signs of coexisting acute systemic illnesses (meningitis, sepsis, and bronchitis pneumonia), Immunodeficiencies and malignancy. Patient’s undergone operative treatment for otitis media, pharyngitis, tonsillitis, and lower respiratory tract infections. Patients under corticosteroids and/or immunosuppressive drugs for any systemic disease.

Design outcomes

Primary

MeasureTime frame
Median duration of hospitalization for children below five years old is seven days. Incidence and recurrence of illness will be measure for the past 12 months in two arms. Mean duration of illness, incidence and recurrence of ARI after supplementation of probiotic curd will be known. Timepoint: There will be 2 end points of the intervention: 1)First end Point-Admission to Discharge after initial management. Throat swabs will be taken to measure levels of inflammatory markers. 2)Second end point: At the end of hospital stay and discharge from hospital till 3 months will be termed second end point. 3)Detailed history and follow up details will be taken from the parents regularly at weekly intervals from 2nd end point to 3 months after discharge.

Secondary

MeasureTime frame
Improvement of nutritional indicators after 3months supplementation, frequency of ARI and hospitalization in both arms. Grade of severity will be measured by frequency of symptoms of illness during admission after supplementation of probiotic curd. No of episodes of recurrent illness after initial management The effect of probiotic curd supplementation in improvement nutritional status, adverse effects and recurrence of ARI for 3 months follow up. Timepoint: 0, 3 months

Countries

India

Contacts

Public ContactDr P Raghavendra

ICMR - National Institute of Nutrition

drraghunin@gmail.com9490418637

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026