Unknown NA INTERVENTIONAL 2-arm NCT02094092

Role of ProTectis on Infant Colic and Its Effect on Infant Crying Time and Maternal Mental Health (PRIC-SMM)

L.Reuteri ProTectis DSM 17938 to Relieve Infant Colic and Its Effects on Infant Sleep Pattern & Maternal Mental Health. PRIC-SMM Trial

Sponsor: Ferozsons Laboratories Ltd.

Conditions Infant Sleeping Habits Infantile Colic Maternal Mental Health.

Interventions Placebo drops (five drops per day) for 21 days ProTectis drops (five drops per day) for 21 days

Updated 5 times since 2017 Last updated: Mar 19, 2014 Started: May 31, 2014 Primary completion: Mar 31, 2016 Completion: Mar 31, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02094092, this NA trial focuses on Infant Sleeping Habits and Infantile Colic and remains ongoing. Sponsored by Ferozsons Laboratories Ltd., it has been updated 5 times since 2014, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Unknown NA
Jul 2024 — Sep 2024 [monthly]

Unknown NA

Status: Unknown Status → Unknown
Jan 2021 — Jul 2024 [monthly]

Unknown Status NA
Jun 2018 — Jan 2021 [monthly]

Unknown Status NA
Jan 2017 — Jun 2018 [monthly]

Unknown Status NA

First recorded

May 2014

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Ferozsons Laboratories Ltd.

Data source: Ferozsons Laboratories Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Rawalpindi, Pakistan