Efficacy and Safety of a Colic Relief Remedy in Infantile Colic
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Published on: July 27, 2022
Charles Evans1, Wladimir P Lorentz2
1New Beginnings Pediatrics, Phillipsburg, NJ, USA.
Insights
This study found that a 14-day colic relief remedy significantly reduced infant crying time and flatulence. The positive effects on infant colic symptoms were sustained even after the treatment period concluded.
Area of Science:
- Pediatrics
- Gastroenterology
- Clinical Pharmacology
Background:
- Infantile colic is a common cause of infant and parental distress.
- Existing treatments for infantile colic have varying efficacy and tolerability.
- There is a need for effective and safe interventions to manage colic symptoms.
Purpose of the Study:
- To evaluate the efficacy of a 14-day colic relief remedy in reducing infant crying time.
- To assess the impact of the remedy on infant sleep patterns and gastrointestinal symptoms.
- To determine the tolerability and sustained effect of the colic relief product.
Main Methods:
- An open-label, single-group clinical study was conducted.
- Thirty infants (3-16 weeks old) with colic were enrolled.
- The remedy was administered orally (1.25 ml) during colic episodes for 14 days.
Main Results:
- Significant reduction in daily inconsolable crying time and flatulence was observed within one week (P < .05).
- The product effectively reduced abdominal distension and pain.
- Sustained improvement in colic symptoms was noted after product discontinuation.
Conclusions:
- The colic relief remedy demonstrated significant efficacy in reducing infant crying and associated gastrointestinal symptoms.
- The product was well-tolerated and provided a sustained therapeutic effect.
- This intervention offers a promising option for managing infantile colic.
Abstract:
Infantile colic is the most frequent reason of infant and parental distress. An open-label single-group clinical study was conducted primarily to evaluate the effect of 14-day colic relief remedy administration (1.25 ml orally during colic episode) on average daily crying time in infants compared to baseline. In addition, the percentage of responders, sleep pattern, frequency and severity of gastrointestinal symptoms, tolerability of the product and percentage population with relapse of symptoms post product discontinuation were evaluated. Thirty infants aged 3 to 16 weeks with no significant clinical illness were enrolled in the study with their caregivers. Daily inconsolable crying time and flatulence were significantly reduced (P < .05) within a week of intervention and a sustained effect was observed after discontinuation of the product. The findings of the present study indicate that this product effectively reduced abdominal distension and pain, resulting in a significant decrease in the daily crying of the infants. Trial registration: The study was registered with the Clinical Trials Registry India (CTRI) (http://ctri.nic.in/Clinicaltrials/login.php) bearing Reg. No: CTRI/2021/03/031762, Date: March 8, 2021.
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