Trial Outcomes & Findings for Probiotics and Infections in Conscripts in Military Service (NCT NCT01651195)

Results Overview

The number of sick days with respiratory and gastrointestinal symptoms and symptom incidence. Other outcome measures were the number and duration of infection episodes, the number of antibiotic treatments received, and the number of days out of service due to an infection. Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers. If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

983 participants

Primary outcome timeframe

Through study completion, an average of 4 months

Results posted on

2021-06-14

Participant Flow

Sample size was calculated on the assumption that the use of probiotic would result in a 17% reduction in the number of sick days estimated that, with a power of 85% and at a significance level of 0.05 (Power 0.85, ß=0.15000 and α=0.05), we needed 300 conscripts per group to show a 17% difference between the groups. Each conscript was randomly allocated to the probiotic or the control group according to a computer generated, 8-blocked randomization list.

Participant milestones

Participant milestones
Measure	Probiotic Tablet (Military Recruits) Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic	Placebo Tablet (Military Recruits) Chrystalline celluloce 2 x 2, 3 weeks Placebo	Probiotic Tablet (Reserve Officer Candidates) Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic	Placebo Tablet (Reserve Officer Candidates) Chrystalline celluloce 2 x 2, 3 weeks Placebo
Overall Study STARTED	284	284	204	211
Overall Study COMPLETED	63	73	121	103
Overall Study NOT COMPLETED	221	211	83	108

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Probiotic Tablet (Military Recruits) n=284 Participants Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic	Placebo Tablet (Military Recruits) n=284 Participants Chrystalline celluloce 2 x 2, 3 weeks Placebo	Probiotic Tablet (Reserve Officer Candidates) n=204 Participants Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks Probiotic	Placebo Tablet (Reserve Officer Candidates) n=211 Participants Chrystalline celluloce 2 x 2, 3 weeks Placebo	Total n=983 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=284 Participants	0 Participants n=284 Participants	0 Participants n=204 Participants	0 Participants n=211 Participants	0 Participants n=983 Participants
Age, Categorical Between 18 and 65 years	284 Participants n=284 Participants	284 Participants n=284 Participants	204 Participants n=204 Participants	211 Participants n=211 Participants	983 Participants n=983 Participants
Age, Categorical >=65 years	0 Participants n=284 Participants	0 Participants n=284 Participants	0 Participants n=204 Participants	0 Participants n=211 Participants	0 Participants n=983 Participants
Sex: Female, Male Female	0 Participants n=284 Participants	0 Participants n=284 Participants	0 Participants n=204 Participants	0 Participants n=211 Participants	0 Participants n=983 Participants
Sex: Female, Male Male	284 Participants n=284 Participants	284 Participants n=284 Participants	204 Participants n=204 Participants	211 Participants n=211 Participants	983 Participants n=983 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Finland	284 participants n=284 Participants	284 participants n=284 Participants	204 participants n=204 Participants	211 participants n=211 Participants	983 participants n=983 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 4 months

Population: According to the study nurse, the file containing number of sick days data of this particular study is no more available.

The number of sick days with respiratory and gastrointestinal symptoms and symptom incidence. Other outcome measures were the number and duration of infection episodes, the number of antibiotic treatments received, and the number of days out of service due to an infection. Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers. If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through study completion, an average of 4 months

Respiratory infection episodes and symptomatic days were counted by the basis of respiratory infection symptoms recorded into the symptom diary and from the medical visits to health care centers.

Outcome measures

Outcome measures
Measure	Probiotic Tablet (Military Recruits) n=411 Episodes Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Placebo Tablet (Military Recruits) n=402 Episodes Crystalline cellulose 2 x 2, 3 weeks	Probiotic Tablet (Reserve Officer Candidates) n=56 Episodes Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Placebo Tablet (Reserve Officer Candidates) n=101 Episodes Crystalline cellulose 2 x 2, 3 weeks
Number and Duration of Infection Episodes	33 Episodes	35 Episodes	30 Episodes	29 Episodes

SECONDARY outcome

Timeframe: Through study completion, an average of 4 months

Number of antibiotic treatments received were collected during the medical visits.

Outcome measures

Outcome measures
Measure	Probiotic Tablet (Military Recruits) n=91 Treatments Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Placebo Tablet (Military Recruits) n=88 Treatments Crystalline cellulose 2 x 2, 3 weeks	Probiotic Tablet (Reserve Officer Candidates) n=17 Treatments Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Placebo Tablet (Reserve Officer Candidates) n=31 Treatments Crystalline cellulose 2 x 2, 3 weeks
Number of Antibiotic Treatments Received	15 Treatments	23 Treatments	2 Treatments	1 Treatments

SECONDARY outcome

Timeframe: Through study completion, an average of 4 months

If the conscript showed minimum of two RTI symptoms for a period of one day or one RTI symptom for a period of two days a RTI episode was considered to be present. Between two episodes a minimum of seven days of non-symptomatic period should be experienced if to be considered as two separate infections. If there were less non-symptomatic days, it was considered to be a continuation of the same infection episode. Symptomatic days were days when at least one symptom was experienced. Gastrointestinal tract infection episodes and symptom days were calculated in the same fashion except 14 non symptomatic days should be in between the two to be considered as two different episodes.

Outcome measures

Outcome measures
Measure	Probiotic Tablet (Military Recruits) n=150 Days Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Placebo Tablet (Military Recruits) n=150 Days Crystalline cellulose 2 x 2, 3 weeks	Probiotic Tablet (Reserve Officer Candidates) n=90 Days Lactobacillus rhamnosus 8-9 x 10 -9 2 x 2 3 weeks	Placebo Tablet (Reserve Officer Candidates) n=90 Days Crystalline cellulose 2 x 2, 3 weeks
Number of Days Out of Service Due to an Infection	44 Days	41 Days	4 Days	6 Days

Adverse Events

Probiotic Tablet (Military Recruits)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Tablet (Military Recruits)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Probiotic Tablet (Reserve Officer Candidates)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Tablet (Reserve Officer Candidates)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Anne Pitkäranta

Helsinki University Central Hospital

Phone: +358406430511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place