Trial Outcomes & Findings for Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies (NCT NCT02349711)

Results Overview

MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

224 participants

Primary outcome timeframe

up to 8 weeks from date of randomization

Results posted on

2017-06-09

Participant Flow

Participants were recruited from the Gainesville, FL area, including the University of Florida campus. Recruiting began in January of 2015 and took place in facilities within the Food Science and Human Nutrition Department at the University of Florida. Participants were enrolled from 1-20-15 to 3-12-15.

Before randomization, participants provided anthropometric measurements and demographic information. Out of the 224 participants who consented to participate, only 173 remained at randomization due to the participants no longer being interested or not coming to their study visits to be randomized.

Participant milestones

Participant milestones
Measure	Placebo Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
Overall Study STARTED	87	86
Overall Study COMPLETED	84	84
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Probiotics and Health-related Quality of Life in Individuals With Seasonal Allergies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=87 Participants Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture n=86 Participants A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.	Total n=173 Participants Total of all reporting groups
Age, Continuous	27.6 years STANDARD_DEVIATION 13.1 • n=5 Participants	26.0 years STANDARD_DEVIATION 10.8 • n=7 Participants	26.8 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	54 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	32 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 8 weeks from date of randomization

Population: Because this was an intent-to-treat study, all data from all randomized participants was considered for analysis. No imputation was done, so missing values excluded a participant from the analysis. While data from a participant may be missing, they were considered to have "completed" the study if they completed all study visits.

MiniRQLQ, global score (0=not troubled, 6=extremely troubled; an average of the 14 questions; includes all domains)

Outcome measures

Outcome measures
Measure	Placebo n=80 Participants Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture n=81 Participants A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
Change in Health-related Quality of Life Score From Baseline to the Peak Week of Allergy Season for Probiotic Versus Placebo, as Measured by MiniRQLQ	-0.1946 units on a scale Standard Error 0.1386	-0.6772 units on a scale Standard Error 0.1302

SECONDARY outcome

Timeframe: baseline and week 6

Population: A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples.

Serum total immunoglobulin E (IgE) was quantified via ELISA

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture n=35 Participants A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
Serum Total Immunoglobulin E (IgE) Week 6	352.6111111 ng/mL Standard Error 56.5615450	843.3428571 ng/mL Standard Error 107.3421604
Serum Total Immunoglobulin E (IgE) Baseline	325.3243243 ng/mL Standard Error 51.4187025	781.0285714 ng/mL Standard Error 103.2435603

SECONDARY outcome

Timeframe: weeks 0, 1, 2, 3, 4, 5, 6, 7

Population: Since this outcome had more than two time points, and since all randomized participants provided some weeks of survey data, all participants were included in the analysis (even those that were lost to follow up). The number of values (and thus the number analyzed) by week is also shown.

Symptoms included in this score are constipation, hard stools, and feeling of incomplete evacuation reported on a weekly Gastrointestinal Symptom Response Scale (GSRS) questionnaire. Questionnaire asks participants about the previous seven days. Scores range from 1 (no discomfort) to 7 (very severe discomfort); lower scores are more desirable.

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture n=86 Participants A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 7	1.65 units on a scale Standard Error 0.08	1.31 units on a scale Standard Error 0.06
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 0	1.57 units on a scale Standard Error 0.09	1.51 units on a scale Standard Error 0.08
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 1	1.51 units on a scale Standard Error 0.08	1.49 units on a scale Standard Error 0.08
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 2	1.59 units on a scale Standard Error 0.09	1.53 units on a scale Standard Error 0.08
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 3	1.68 units on a scale Standard Error 0.09	1.42 units on a scale Standard Error 0.07
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 4	1.73 units on a scale Standard Error 0.11	1.41 units on a scale Standard Error 0.07
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 5	1.61 units on a scale Standard Error 0.08	1.48 units on a scale Standard Error 0.07
Constipation Symptom Score, Measured by Gastrointestinal Symptom Response Scale (GSRS) Questionnaire Week 6	1.60 units on a scale Standard Error 0.08	1.37 units on a scale Standard Error 0.06

SECONDARY outcome

Timeframe: baseline and week 6

Population: A subgroup of participants who completed the main study (questionnaire data only) also completed an additional portion of the study in which they provided blood and stool samples. Some samples could not be accurately measured for this outcome, so those samples were excluded from analysis.

Regulatory T cells (Tregs) as a percentage of CD4+ T cells, quantified via flow cytometry

Outcome measures

Outcome measures
Measure	Placebo n=35 Participants Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.	Probiotic Mixture n=35 Participants A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
Regulatory T Cells (Tregs) Baseline	4.1931 percentage of CD4+ T lymphocytes Standard Error 0.2427	4.4146 percentage of CD4+ T lymphocytes Standard Error 0.2533
Regulatory T Cells (Tregs) Week 6	4.7733 percentage of CD4+ T lymphocytes Standard Error 0.2004	4.8626 percentage of CD4+ T lymphocytes Standard Error 0.2007

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Probiotic Mixture

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

Dr. Bobbi Langkamp-Henken

Food Science and Human Nutrition Department, University of Florida

Phone: 352-294-3721

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI shall provide the sponsor copies of any proposed publication or presentation at least 30 days in advance of submission to a journal, editor, or other third party to allow sponsor to determine whether patentable subject matter or sponsor's confidential information would be disclosed.
Publication restrictions are in place

Restriction type: OTHER