FindTrial
Sign In

To Evaluate the Safety and Efficacy of Oral administration of Tep-AD�® (probiotic Lactobacillus salivarius) in Indian Children having by Moderate and Severe Atopic Dermatitis.

Open label, Multicentric, Comparative, Randomized Clinical Study to Evaluate the Safety and Efficacy of Oral administration of Tep-AD�® (probiotic Lactobacillus salivarius) in Indian Children having by Moderate and Severe Atopic Dermatitis.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/01/039781
Enrollment
60
Registered
2022-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Inzpera Healthsciences Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or female children between 0-11 years of age (both inclusive) Suffering from moderate or severe atopic dermatitis. Children and parents / guardians who agree to comply with study requirement and schedule. Parents or legal guardians willing to sign written informed consent form for the child and child willing to sign assent form for participation (if old enough to understand his /her participation in study)

Exclusion criteria

Exclusion criteria: 1. Use of analgesics within the study. 2. Use of antibiotics within the study. 3. Subjects with any other chronic illness such as acute asthma, heart blocks, any congenital anomaly. 4. Subjects with chronic and infectious diseases. 5. Subjects with hypersensitivity to any components contained in the probiotic sachets. 6. Inability to keep return appointments. 7. Participated in any clinical investigation in the last 30 days. 8. Not found suitable as per discretion of investigator

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Tep-ADÃ?® (probiotic formulation containing Lactobacillus salivarius-2Ã?â??10â?¹ CFU/sachet) when administered orally for the treatment of moderate and severe atopic dermatitis (AD) in children using: i. Objective SCORAD / SCORAD index ii. Itch indexTimepoint: Timepoints will be assessed in all visits.—

Secondary

MeasureTime frame
Patient reported outcomes of worsening of any baseline symptoms evaluated at every visit until post treatment follow-up visit. Changes in the vital parameters; body temperature, pulse rate, respiratory rate from baseline to the end of treatment. Physicians Global Assessment at the end of the study using 4-point scale. The steroid sparing measure due to Tep-ADÃ?® in the investigational Arm.Timepoint: Timepoints will be assessed in all visits.—

Countries

India

Contacts

Public ContactDivya C

Bioagile Therapeutics Pvt. Ltd

divya@bioagiletherapeutics.com09538961761

Outcome results

None listed

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