Plain English Summary
Background and study aims
Infant with persistent crying/fussing is a behavioral problem in early infancy that involve long crying bouts and hard-to-soothe behavior for no apparent cause. The parents and caretakers often seek many treatments for these babies including the use of several drugs with serious side effect, vegetable fiber, lactose, sucrose solution, hypoallergenic diet, and herbal tea. But there still is no single effective and safe intervention or drug for babies’ colic. Recent studies have reported that gut microbiota in these infants is imbalanced by lower amounts of beneficial bacterial and higher amounts of harmful bacterial. Thus, several researchers have suggested that specific probiotics may be useful for improving imbalance gut bacterial and reducing babies’ crying time.
This study sought to explore the effectiveness of the two-combined probiotic strains in treating babies’ crying and fussing.
Who can participate?
Babies aged under 12 weeks, with persistent crying/fussing
What does the study involve?
Eligible colic infants are randomly allocated to receive either the two specific probiotics by oil drops as the intervention group (IG) or a reference oil drop without probiotics as the placebo group (PG). Babies’ caregivers administer five drops of one of the product orally to each infant daily for 21 days. Babies’ caregivers are taught to use the Baby’s Dietary to record the infant crying/fussing time and the frequency, the numbers of babies who were responding to the treatment, stool consistency, and frequency of stool.
What are the possible benefits and risks of participating?
The babies who are taking part in the study can decrease their crying/fussing behaviors, improve their fecal consistency and frequency and increase the caregivers’ life quality during the intervention. The two specific strains in the investigational product are very safe and suitable for infant who meeting the inclusion criteria. And if an event occurs related to the conduct of the study or the development of the test product which may affect the safety of the study subjects, the founder and the study investigator may take appropriate measures to protect the subjects against immediate hazards.
Where is the study run from?
1. Angel Children’s Hospital, Chengdu, China
2. Qingbaijiang Maternal and Child Health Hospital, China
3. Chengdu Caojiaxiang Community Healthcare Center, China
4. Huili Maternity and Child Care Center, China
When is the study starting and how long is it expected to run for?
June 2018 to November 2019
Who is funding the study?
Maternal and Infant Health and Care Science Laborotory, China
Who is the main contact?
Dr Ke Chen
263662086@qq.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ke Chen
ORCID ID
https://orcid.org/0000-0001-7455-0900
Contact details
No.1617
Riyue Avenue
Qingyang district
Chengdu
610031
China
+86-028-61866036
263662086@qq.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
MIHC/2017/10/AKO2018
Study information
Scientific title
The efficacy of three weeks’ daily supplementation with two-combined probiotic strains on infant colic
Acronym
Study hypothesis
In comparison to the placebo group, the two-combined probiotic strains, B. longum CECT7894 (KABP042) and P. pentosaceus CECT8330 (KABP041), would reduce mean daily crying or fussing time, decrease daily episodes of crying or fussing, and improve the pediatric quality of life inventory after the intervention.
Ethics approval
Approved 05/03/2018, Institutional ethics committee of Angel Children’s Hospital (No.46-1 Section 4 South Renmin Road Wuhou District, Chengdu City, Sichuan Province, 610042, China; +86-028-67899999-8063; no email provided), ref: 2018004
Study design
Randomized double-blinded placebo-controlled parallel-group multicentre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Colic
Intervention
All eligible colic infants are randomized to receive either the probiotics as the intervention group (IG) or a reference product without probiotics as the placebo group (PG). The probiotic formula, comprising a sunflower oil suspension of the strains B. longum CECT7894 (KABP042) and P. pentosaceus CECT8330 (KABP041), contains 1 billion Colony-Forming Units (CFU) in each drop (1:1 for the two strains). Five drops (equal to 1 billion CFU) are taken once daily preferably at the same time of the day, e.g. in the morning. The reference product (placebo) is an identical sunflower oil without probiotics. Both the probiotics and the placebo are produced by AB-Biotics S.A.
Caregivers administer five drops of the study product orally to each infant daily for 21 days. The dose is not required to be given at a fixed time or given with feeds. However, for compliance and ease of administration, each family is recommended to give the dose with the same feed each day. The total duration of follow-up for all study arms is 13 months.
Randomization:
A blocked randomization schedule that maintains a balance between treatment arms will be prepared by an independent statistician, not directly involved in the analysis of the study results. The RAND function of Excel (Microsoft, Redmond, WA, USA) will be used to generate randomly permutated codes. To minimize potential biases, the study is double-blinded whereby treatment allocation is concealed from all study investigators and participants.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
Mean daily crying or fussing time measured using parental self-report each day of the intervention
Secondary outcome measures
1. Number of daily episodes of crying or fussing measured using parental self-report each day of the intervention.
2. Infant quality of life measured using the pediatric quality of life inventory at the 7th, 14th and 21st day after the intervention
Overall trial start date
01/09/2017
Overall trial end date
01/11/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Crying or fussing episodes lasting more than 3 hours per day and occurring at least 3 days per week within 7 days prior to enrollment (ROME IV criteria)
2. Less than 3 months (12 weeks) of age
3. Equal to or greater than 37 weeks of gestation at birth
4. Vaginal delivery
5. Birth weight of more than 2500g
6. Provided voluntary written informed consent from parents of the infant
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
112
Total final enrolment
112
Participant exclusion criteria
1. Average weight gain < 100 grams/week from birth to the last recorded weight
2. Major medical problems (e.g. immunocompromised disease, major developmental or genetic abnormality)
3. Gastrointestinal disorder
4. Taking antibiotics four weeks prior to enrollment
5. Using the same probiotic strains in this study two weeks prior to enrollment
6. Taking antibiotics during the intervention
Recruitment start date
01/06/2018
Recruitment end date
01/06/2019
Locations
Countries of recruitment
China
Trial participating centre
Qingbaijiang Maternal and Child Health Hospital
Qingbaijiang
610300
China
Trial participating centre
Chengdu Caojiaxiang Community Healthcare Center
Chengdu
610084
China
Trial participating centre
Huili Maternity and Child Care Center
Huili
615100
China
Trial participating centre
Angel Children’s Hospital
Chengdu
610042
China
Sponsor information
Organisation
Angel Children’s Hospital
Sponsor details
No.46-1 Section 4
South Renmin Road
Wuhou District
Chengdu
610042
China
86-13981782973
263662086@qq.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Maternal and Infant Health and Care Science Laborotory
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list