Plain English Summary
Background and study aims
Acute gastroenteritis (AGE) is a common condition which involves sudden inflammation (swelling) of the lining of the stomach due to a viral infection. It affects people of all ages, but is most common in young children. One of the main symptoms is diarrhoea, which if lasts for more than three days can be cause severe dehydration (loss of fluids). Probiotics are living microorganisms, which are thought to have a positive influence health. Among the most commonly used are lactic bacteria, as they are naturally present in the gut and help with digestion (so called “good bacteria”). Probiotics are mainly available as food additives, such as yogurts, or in supplements. Bio-Kult Infantis is an advanced, multi-strain formula for babies, toddlers and young children containing seven strains of live bacteria with addition of prebiotics, Omega-3 fatty acids and Vitamin D3. Previous studies have shown that it can be beneficial in the treatment of gastroenteritis symptoms and can help speed up diarrhoea recovery. This may be due to the probiotic replenishing the “good bacteria” lost as a result of the diarrhoea. The aim of the study is to investigate the effectiveness of Bio-Kult Infantis in the treatment of diarrhoea.
Who can participate?
Children aged between six months and six years that seek medical attention for AGE and receive rehydration therapy but do not have to stay in hospital.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group eat the Bio-Kult Infantis product once a day for seven days. Participants in the second group eat a placebo (dummy) formula for seven days. For both groups, if there is no improvement within seven days, the researcher can extend the length of treatment to ten days. Parents of children in both groups are given a diary in which they are asked to record the number of diarrhoea episodes. Once week after the end of treatment, parents of children in both groups are telephoned in order to check when the diarrhoea stopped and to find out if there were any side effects from the formula.
What are the possible benefits and risks of participating?
Participants who receive the Bio-Kult Infantis may benefit from a faster recovery from their diarrhoea. Bio-Kult Infantis, has been on the market for some time and there have been no confirmed negative reactions reported in connection its use. Therefore, there are no predicted risks for children taking part.
Where is the study run from?
Three hospitals in Croatia and 20 hospitals in Slovenia.
When is the study starting and how long is it expected to run for?
September 2015 to March 2018
Who is funding the study?
Probiotics International Ltd. (Protexin) (UK)
Who is the main contact?
Mrs Mojca Fir
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
BKI-01
Study information
Scientific title
Randomized, 2 arm, parallel, double-blind, placebo-controlled clinical study to evaluate the efficacy of probiotic product Bio-Kult Infantis as adjuvant therapy in treatment of acute gastroenteritis in children
Acronym
Infantis
Study hypothesis
The aim of the study is to show the effectiveness of Bio-Kult Infantis as an adjuvant therapy in treating acute diarrhoea, compared to placebo.
Ethics approval(s)
National Medical Ethics Comittee of Republic of Slovenia
Study design
Paediatric multi-centre randomized double-blind 2 arm parallel placebo-controlled clinical study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Home
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Acute gastroenteritis (AGE) with evidence of dehydration
Intervention
Participants are randomised to one of two study arms in a 1:1 ratio using envelope randomisation.
Treatment arm: Participants receive Bio-Kult Infantis (an advanced probiotic multi-strain formula for infants with addition of prebiotics, omega 3 and vitamin D3) once a day for seven days, with an option to prolong teatment to ten days if no improvement is observed. The prolongation of the treatment will be the decision of the Investigator.
Control arm: Participants receive a placebo (product without probiotic organisms, prebiotics, omega-3 or vitamin D3 containing 100% maltodextrin) once a day for seven days, with an option to prolong teatment to ten days if no improvement is observed. The prolongation of the treatment will be the decision of the Investigator.
A week after the last dose of study treatment (i.e. day 15), the follow-up phone call will be performed to check the overall status of the patient and check for eventual adverse events.
The total duration of study per patient will be at least 15 days, and up to 18 days in case of the prolonged treatment.
Intervention type
Supplement
Primary outcome measure
Duration of diarrhoea – “time to last diarrheal stool” is measured as the time in hours since the first time the Study Product is given until the last liquid/loose stool in the last 24 hours with at least three liquid/loose defecations.
Secondary outcome measures
Number of diarrheal episodes per day (frequency of defecation) is measured from patient diaries completed daily by the patient's caregiver throughout the study period.
Overall study start date
01/09/2015
Overall study end date
31/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient Informed Consent (PIC) form signed by parent or legal guardian
2. Aged between 6 months and 6 years (up to the age of 5 years and 11 months) at the time of the signature of PIC
3. Confirmed acute diarrhoea according to WHO (at least 3 loose or watery stools within last 24h), which lasted less than 2 days (< 48 h) prior to signature of PIC
4. Diagnosed with acute gastroenteritis with evidence of dehydration (evaluated according to CDS) and in need of rehydration therapy (oral or IV)
5. Only patient treated in an out-patient setting (i.e. managed in an A+E department without subsequent hospitalization) is eligible; if it is decided that the patient needs to be hospitalized, he or she should not be included in the study
Participant type(s)
Patient
Age group
Child
Lower age limit
6 Months
Upper age limit
5 Years
Sex
Both
Target number of participants
186
Participant exclusion criteria
1. Patient diagnosed with gastroenteritis, but it is determined that they don’t need rehydration treatment (Score 0 according to CDS)
2. Patient who received antibiotic treatment within the last two months prior to onset of gastroenteritis
3. Patient who was taking probiotic supplements, dairy product with high bacterial count, such as Actimel or Yakult, or milk formula with probiotics, in the last month prior to onset of gastroenteritis (consumption of normal yoghurts is acceptable)
4. Patient who has to be hospitalized
5. Patient who is exclusively breastfed
6. Patient with diabetes
7. Immuno-compromised patient or patient with other severe chronic disorders that might influence the outcome of study therapy (as evaluated by Investigator)
8. Patient with oedema
9. Malnutrition (< 3% EBW; under the 3rd percentile of expected body weight)
10. Known lactose or gluten intolerance
11. Known allergy to cow’s milk proteins, fish, or any of the substances of the probiotic product or placebo
12. Patient who already participated and completed this study, and has repeated gastroenteritis while the enrolment into the study is still open
13. Patient participating in any other interventional clinical study
14. Patient with confirmed bacterial AGE and/or patient who need antibiotic treatment, will be excluded from the study
Recruitment start date
15/07/2016
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Croatia, Slovenia
Study participating centre
General Hospital Jesenice
Department of Paediatrics
Cesta maršala Tita 112
Jesenice
4270
Slovenia
Study participating centre
General Hospital Novo mesto
Department of Paediatrics
Šmihelska cesta 1
Novo mesto
8000
Slovenia
Study participating centre
University Medical Centre Ljubljana
Department of Paediatrics
Zaloška cesta 7
Ljubljana
1000
Slovenia
Study participating centre
University Hospital Centre Osijek
Department of Paediatrics
Joseph Huttlera 4
Osijek
31000
Croatia
Study participating centre
University Hospital Centre Rijeka
Department of Paediatrics
Krešimirova 42
Rijeka
51000
Croatia
Study participating centre
Hospital for Infectious Diseases "Dr Fran Mihaljevic"
Department of Paediatrics
Mirogojska 8
Zagreb
10000
Croatia
Study participating centre
Barsos-Mc, Zdravstvene Storitve d.o.o.
Gregorčičeva ulica 11
Ljubljana
1000
Slovenia
Study participating centre
Health Centre of dr. Julij Polc Kamnik
Novi trg 26
Kamnik
1241
Slovenia
Study participating centre
Health Centre Grosuplje
Pod gozdom c. I/14
Grosuplje
1290
Slovenia
Study participating centre
Health Centre Ivančna Gorica
Cesta 2. grupe odredov 16
Ivančna Gorica
1295
Slovenia
Study participating centre
Health Centre Trebnje
Goliev trg 3
Trebnje
8210
Slovenia
Study participating centre
Health Centre Novo mesto
Kandijska cesta 4
Novo mesto
8000
Slovenia
Study participating centre
Health Centre Krško
Cesta Krških žrtev 132 c
Krško
8270
Slovenia
Study participating centre
Health Centre Brežice
Černelčeva cesta 8
Brežice
8250
Slovenia
Study participating centre
Health Centre of dr. Franc Ambrožič
Prečna ulica 2
Postojna
6230
Slovenia
Study participating centre
Health Centre Koper
Dellavallejeva ulica 3
Koper
6000
Slovenia
Study participating centre
Dr. Daneu, d.o.o.
Cesta solinarjev 1
Portorož
6320
Slovenia
Study participating centre
Health Centre Nova Gorica
Rejčeva ulica 4
Nova Gorica
5000
Slovenia
Study participating centre
Health Centre Šentjur
Cesta Leona Dobrotinška 3b
Šentjur
3230
Slovenia
Study participating centre
Ambulanta za vse generacije d.o.o.
Potrčeva cesta 15
Ptuj
2250
Slovenia
Study participating centre
Zasebna pediatrična ambulanta dr. Zrilić
Potrčeva cesta 15
Ptuj
2250
Slovenia
Study participating centre
Pediatrija d.o.o
Kalohova ulica 18
Maribo
2000
Slovenia
Study participating centre
Pediatrinja d.o.o.
Hrenova ulica 6
Maribor
2000
Slovenia
Study participating centre
Health Centre Murska Sobota
Grajska ulica 24
Murska Sobota
9000
Slovenia
Sponsor information
Organisation
Probiotics International Ltd. (Protexin)
Sponsor details
Lopen Head
Somerset
Somerset
TA13 5JH
United Kingdom
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Probiotics International Ltd. (Protexin)
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.
Intention to publish date
31/05/2019
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from the study contact.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|