Clinical study to evaluate the efficacy of probiotic product Bio-Kult Infantis as concomitant treatment of acute infectious diarrhoea in children
| ISRCTN | ISRCTN12919460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12919460 |
| Secondary identifying numbers | BKI-01 |
- Submission date
- 13/07/2016
- Registration date
- 14/07/2016
- Last edited
- 12/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Contact information
Scientific
Vizera d.o.o.
Vojkova 4
Ljubljana
1000
Slovenia
Study information
| 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 |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study 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 |
| 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 |
Eligibility
| 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 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 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 centres
Cesta maršala Tita 112
Jesenice
4270
Slovenia
Šmihelska cesta 1
Novo mesto
8000
Slovenia
Zaloška cesta 7
Ljubljana
1000
Slovenia
Joseph Huttlera 4
Osijek
31000
Croatia
Krešimirova 42
Rijeka
51000
Croatia
Mirogojska 8
Zagreb
10000
Croatia
Ljubljana
1000
Slovenia
Kamnik
1241
Slovenia
Grosuplje
1290
Slovenia
Ivančna Gorica
1295
Slovenia
Trebnje
8210
Slovenia
Novo mesto
8000
Slovenia
Krško
8270
Slovenia
Brežice
8250
Slovenia
Postojna
6230
Slovenia
Koper
6000
Slovenia
Portorož
6320
Slovenia
Nova Gorica
5000
Slovenia
Šentjur
3230
Slovenia
Ptuj
2250
Slovenia
Ptuj
2250
Slovenia
Maribo
2000
Slovenia
Maribor
2000
Slovenia
Murska Sobota
9000
Slovenia
Sponsor information
Industry
Lopen Head
Somerset
Somerset
TA13 5JH
United Kingdom
| Website | http://www.protexin.com |
|---|---|
"ROR" |
https://ror.org/00dv58j78 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from the study contact. |
Editorial Notes
12/01/2018: The recruitment end date has been updated from 31/12/2017 to 31/12/2018. The overall trial end date has been updated from 31/03/2018 to 31/03/2019. The intention to publish date has been updated from 31/05/2018 to 31/05/2019.
22/09/2017: Internal review.
31/07/2017: Recruitment end has been updated from 31/05/2017 to 31/12/2017. Overall trial end date has been updated from 31/07/2017 to 31/03/2018. Intention to publish date has been changed from 31/12/2017 to 31/05/2018.
23/03/2017: 18 additional trial participating centres have been added.
07/12/2016: The overall trial end date has been updated from 31/12/2016 to 31/07/2016 and the recruitment end date has been updated from 30/11/2016 to 31/05/2017.
