Lactobacillus rhamnosus GG (ATCC 53103) in the treatment of infantile colic
| ISRCTN | ISRCTN87937882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87937882 |
| Secondary identifying numbers | 0078279 |
- Submission date
- 08/09/2021
- Registration date
- 09/09/2021
- Last edited
- 03/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English summary of protocol
Background and study aims
Infantile colic is one of the most common problems that occurs within the first months of life with a prevalence of up to 30%. As it is characterized by spells of irritability, fussing or crying that start and stop without obvious cause and lasts 3 or more hours a day, at least 3 days a week for at least 1 week, it may be very distressing to parents. Hence, any safe and effective treatment that ameliorates symptoms like crying time would be desirable.
The influence of probiotics on infant microbiota (gut bacteria) has attracted great interest in the field of infant nutrition after the discovery of human breast milk as a source of these compounds. Growing evidence underlines the fact that infantile colic can be mediated by the composition of the gut flora and immunity. Probiotics may be an important treatment option for managing infantile colic due to their anti-inflammatory properties.
Who can participate?
Breastfed infants aged between 2 and 10 weeks with infantile colic
What does the study involve?
Participants will be randomly allocated to receive five drops of either the probiotic Lactobacillus rhamnosus (ATCC 53103) or placebo daily for 28 days. Crying time per day is measured by parents using a structured diary for the 28 days of the study.
What are the possible benefits and risks of participating?
The possible benefit is the improvement of symptoms due to infantile colic with a reduction of crying time. No risks are known.
Where is the study run from?
Children's Hospital Regina Margherita di Torino (Italy)
When is the study starting and how long is it expected to run for?
July 2021 to February 2023
Who is funding the study?
Dicofarm (Italy)
Who is the main contact?
Dr Savino Francesco
francesco.savino@unito.it
Contact information
Scientific
Piazza Polonia, 94
Torino
10126
Italy
 ORCID ID |
0000-0001-9163-1016 |
|---|---|
| Phone | +39 (0)113135618 |
| francesco.savino@unito.it |
Study information
| Study design | Interventional randomized double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40387_PIS.doc |
| Scientific title | Assay of IL6 and TNF alfa in infantile colic treated with Lactobacillus GG |
| Study objectives | Probiotics may be an important treatment option for managing infantile colic due to their anti-inflammatory properties. This study aims to assess IL6 and TNF alfa with real-time PCR before and after administration of Lactobacillus GG. |
| Ethics approval(s) | Approved 22/07/2021, Comiato Etico interaziendale AUO Città della salute AUO ospedale Mauriziano di Torino (Corso Bramante, 88/90 - 10126 Torino, Italy; +39 (0)11 6331633; email: not known), ref: P.I./Cod. Fisc. 10771180014, Prot. n° 0078279 Titolario A/2.4.8 |
| Health condition(s) or problem(s) studied | Infantile colic |
| Intervention | At enrollment, each infant underwent a medical examination by a pediatrician, and parents completed a questionnaire to obtain data concerning the type of delivery, birth weight, and gestational age. The doctor interviewed parents and asked them to report full-force crying by means of a well-validated three-day diary before the fecal sample collection. A diet eliminating cow’s milk and dairy products for the breastfeeding mother was requested. The mean daily minutes of crying was calculated as a sum of crying, fussing, and unsuitable crying using a parental diary. Participants are randomized to take five drops of Lactobacillus rhamnosus (ATCC 53103) (5 × 10e9 colony for units per day) or placebo for a 28-day study period. Randomization was done using a random-digit method, on the basis of computer-generated numbers. The researchers used a two treatments randomization scheme with a random block of varying size (Stata Statistical Software: Release 9. StataCorp LP, College Station, TX, USA. Ralloc Procedure). The probiotic study product consisted of a suspension of freeze-dried L. rhamnousus ATCC53103 in a mixture of maize oil and mono and diglyceride oil supplied in a 5 ml dark bottle fitted with a dropper cap. The placebo was an identical mixture of maize oil and mono and diglyceride oil in appearance and taste but without the probiotic. Both formulations were administered during the morning in five drops, once a day, 30 min before the feed, for a period of 28 days. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Lactobacillus rhamnosus (ATCC 53103) |
| Primary outcome measure | Crying time per day measured by parents using a structured diary for the 28 days of the study period |
| Secondary outcome measures | Interleukin 6 and tumor necrosis factor alfa evaluated with real-time PCR at day 0 and day 28 |
| Overall study start date | 22/07/2021 |
| Completion date | 28/02/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Weeks |
| Upper age limit | 10 Weeks |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Infants aged between 2 and 10 weeks 2. Gestational age between 37 and 40 weeks 3. Birth weight between 2700 and 4200 g 4. Exclusively breastfed |
| Key exclusion criteria | 1. Clinical evidence of chronic illness or gastrointestinal disorders 2. Received antibiotics or probiotics in the week preceding recruitment |
| Date of first enrolment | 23/07/2021 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Italy
Study participating centre
Torino
10126
Italy
Sponsor information
Industry
Via del casale della Marcigliana, 29
Roma
00138
Italy
| Phone | +39 (0)6 8856131 |
|---|---|
| diofebi@dicofarm.it | |
| Website | http://www.dicofarm.it |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 20/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 09/09/2021 | No | Yes | ||
| Protocol file | 09/09/2021 | No | No | ||
| Abstract results | Abstract: N-PW018 | 14/05/2024 | 03/12/2024 | No | No |
Additional files
Editorial Notes
03/12/2024: Publication reference added.
10/01/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2022 to 31/12/2022.
2. The overall trial end date was changed from 28/02/2022 to 28/02/2023.
3. The intention to publish date was changed from 20/03/2022 to 20/06/2023.
09/09/2021: Trial's existence confirmed by Comiato Etico interaziendale AUO Città della salute AUO ospedale Mauriziano di Torino.
