Condition category
Signs and Symptoms
Date applied
27/11/2019
Date assigned
10/12/2019
Last edited
06/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

06/12/2019: Trial’s existence confirmed by the Maternal and Infant Health and Care Science Laboratory