Recovery study of L. casei DG® (Enterolactis® bevibile) in healthy children

• Register: ISRCTN
• Last refreshed on: 27 May 2019
• Main ID: ISRCTN61742259
• Date of registration: 28/06/2018
• Prospective Registration: No
• Primary sponsor: SOFAR S.p.A.
• Public title: Recovery study of L. casei DG® (Enterolactis® bevibile) in healthy children
• Scientific title: Recovery study of L. casei DG® (Enterolactis® bevibile) in healthy children
• Date of first enrolment: 29/08/2017
• Target sample size: 20
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN61742259
• Study type: Interventional
• Study design: Single-centre open-label one-arm pilot study (Other)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Walter Fiore

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged 3-12 years inclusive
2. Not classified as overweight based on the applicable body mass index chart for sex and age (SSP SGP. Growing curves. http://www.swiss- paediatrics.org/sites/default/files/ recommandations/courbes_de_croissances/pdf/perzentilen_2012_09_15_sgp_i.pdf. Accessed 20/06/2017)
3. Informed consent: informed consent of the parent(s)/legal representative(s) in accordance with Swiss regulations. Children aged =11 years provided informed consent; children aged from 3 to <11 years were not required to provide consent and were informed verbally
4. Full comprehension: ability of the children and/or their parent(s)/legal representative(s) to understand the full nature and purpose of the study, including possible risks and side effects; ability of the children and/or their parent(s)/legal representative(s) to co-operate with the investigator and to comply with the requirements of the entire study

Exclusion criteria:
1. Clinically significant abnormal physical findings which could interfere with the objectives of the study
2. Unusual defecation frequency: on average more than 3 stools per day or less than 3 stools per week, as reported by the child/parent(s)/legal representative(s)
3. Food allergies (known or suspected); ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs/food supplements or allergic reactions in general, which the investigator considered could affect the outcome of the study
4. Intake of antibiotics within 1 month of screening
5. Medications, including over-the-counter medications and herbal remedies within 2 weeks of the start of the study.
6. Significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that could interfere with the aim of the study. In particular:
6.1. Inflammatory intestinal chronic diseases
6.2. Intestinal diseases of infective origin
6.3. Viral or bacterial enteritis episodes in the 2 months before screening
6.4. Gastric or duodenal ulcer episodes in the 5 years before screening
6.5. Ongoing systemic infections
6.6. History of congenital infections
6.7. Neurological diseases
6.8. Metabolic diseases
6.9. Genetic diseases or chromosome anomalies
6.10. Primary or secondary immunodeficiencies
7. Participation in the evaluation of any investigational product in the 3 months before this study. The 3-month interval was calculated as the time between the first calendar day of the month that followed the last visit of the previous study and the first day of the present study
8. Recent history of drug or alcohol abuse
9. Unusual diets or substantial changes in eating habits in the 4 weeks before this study or vegetarian
10. Consumption of probiotics/prebiotics during run-in, including fermented milk probiotics (traditional yoghurt was allowed), probiotics food supplements or any other probiotic-containing product or prebiotic food supplement starting on Day -9
11. Pregnant (females only): urine pregnancy test for children of child-bearing potential
12. Compliance: presence of conditions that in the Investigator's opinion could lead to non-compliance to study requirements


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Survival of Lactobacillus casei DG in the gut of children
Digestive System

Intervention(s)

The study protocol specified a screening visit, a 1-week run-in phase and a 1-week treatment phase followed by a 2-week follow-up phase and a final visit.
All enrolled children received the same treatment, i.e. 1 bottle of Enterolactis® containing 1 billion live cells of L. casei DG®. The subjects drank one bottle of the investigational product daily for 1 week, i.e. for a total of seven doses (seven bottles). Upon opening, the content of the bottle's cap was directly mixed with the solution in the bottle to reconstitute the product. The solution was shaken well. The children drank directly the contents of the bottle, preferably under fasting conditions for at least 2 h, in the morning at least 10 min before breakfast. If the subject forgot or could not take the product in the morning, the bottle contents was consumed in the evening before going to bed and in any case at least 2 h after the last meal of the day. The subject should take the product always at the same time, i.e. either in the morning or in the evening, whichever time was more convenient.
Faecal samples were collected in special sterile containers, provided by the clinical staff to the children/parent(s)/legal representative(s), and were stored at home at approximately 2-8°C. The samples were collected at the following days or up to 2 days after each specified day: baseline, Day 1, Day 4, Day 8, Day 11, Day 14, Day 17, Day 20. Then they were picked up by the courier as soon as possible after defecation. The samples were delivered to Dipartimento per gli Alimenti, la Nutrizione e l'Ambiente (DEFENS), Italy, taking into consideration that processing for primary variable analysis had to be completed by the laboratory within 24 h from sample production.
A diary was provided to the subjects/parent(s)/legal representative(s) at screening, was checked at each visit and was returned to the clinical staff at final visit/ETV. During the whole stu

Primary Outcome(s)

Faecal recovery of viable L. casei DG®, determined on the basis of L. casei DG® colony-forming units (CFU) count

Secondary Outcome(s)

1. Defecation frequency at baseline, during and after treatment (diary)
2. Faecal consistency at baseline, during and after treatment (using the Bristol stool scale)
3. Digestive function evaluation (diary)
4. Product intake global evaluation (question on Day 8 - diary)
5. Faecal microbiota (microbial composition) characterisation (by culture of faecal samples)

Secondary ID(s)

CRO-PK-17-322; PSC-DS RECENT-BS 16

Source(s) of Monetary Support

SOFAR S.p.A.

Ethics review

Status:
Approval date:
Contact:

1. Cantonal Ethics Commitee Ticino, 24/07/2017, Project ID 2017-01231/CE 3246 2. Non-substantial amendment Nr.1, 17/08/2017

Results

• Results available: Yes
• Date Completed: 04/10/2017