Trial Outcomes & Findings for Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia (NCT NCT04256785)

NCT ID: NCT04256785

Last Updated: 2021-08-02

Results Overview

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 110 participants
• Primary outcome timeframe: baseline and twelve weeks after treatment
• Results posted on: 2021-08-02

Participant Flow

Participant milestones

Measure	VSL#3 probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic	Placebo matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo
Overall Study STARTED	54	56
Overall Study COMPLETED	26	31
Overall Study NOT COMPLETED	28	25

Reasons for withdrawal

Measure	VSL#3 probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic	Placebo matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo
Overall Study Adverse Event	8	6
Overall Study Lack of Efficacy	3	4
Overall Study Lost to Follow-up	7	7
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	4	1
Overall Study Surgery or quarantined due to Covid-19	5	7

Baseline Characteristics

Probiotic VSL#3 for the Treatment of Gastrointestinal Symptoms Associated to Fibromyalgia

Baseline characteristics by cohort

Measure	VSL#3 n=54 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic	Placebo n=56 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo	Total n=110 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 7.5 • n=5 Participants	55.5 years STANDARD_DEVIATION 8.6 • n=7 Participants	55.6 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	56 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Weight (Kg)	73.3 kgs STANDARD_DEVIATION 17.7 • n=5 Participants	71.2 kgs STANDARD_DEVIATION 13.4 • n=7 Participants	72.2 kgs STANDARD_DEVIATION 15.6 • n=5 Participants
Fibromyalgia diagnosis - Widespread Pain Index (WPI) total score	15.9 scores on a scale STANDARD_DEVIATION 3.0 • n=5 Participants	16.5 scores on a scale STANDARD_DEVIATION 2.6 • n=7 Participants	16.2 scores on a scale STANDARD_DEVIATION 2.8 • n=5 Participants
Fibromyalgia diagnosis - Symptom Severity Score	9.3 scores on a scale STANDARD_DEVIATION 2.0 • n=5 Participants	9.7 scores on a scale STANDARD_DEVIATION 1.7 • n=7 Participants	9.5 scores on a scale STANDARD_DEVIATION 1.9 • n=5 Participants
Fibromyalgia diagnosis - Fibromyalgia Score	25.3 scores on a scale STANDARD_DEVIATION 4.3 • n=5 Participants	26.2 scores on a scale STANDARD_DEVIATION 3.5 • n=7 Participants	25.7 scores on a scale STANDARD_DEVIATION 3.9 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and twelve weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 12 score - baseline score)

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change, From Baseline to Endpoint (12 Weeks) in the Composite Score of Abdominal Pain, Abdominal Bloating and Metheorism Each One Measured in a 0-10 Visual Analog Scale	-6.5 score on a scale Standard Deviation 9.5	-5.4 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: baseline and twelve weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

The FIQR is a self-reported, validated questionnaire that evaluates the severity of fibromyalgia symptomatology in a scale ranging from 0 to 100 points; the higher the score, the worse the severity of the disease. Change = (week 12 score - baseline score)

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Fibromyalgia Impact Questionnaire Revised (FIQR)	-7.2 score on a scale Standard Deviation 12.5	-12.5 score on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: baseline and twelve weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

The ISI is a self-reported, validated questionnaire that measures the severity of sleep disturbances in a scale ranging from 0 to 28 points: higher scores indicate more severe sleep disturbance

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Insomnia Severity Inventory (ISI)	-1.7 score on a scale Standard Deviation 5.9	-1.2 score on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: baseline and twelve weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

PHQ-9 is a self-reported, validated questionnaire that measures the severity of depression in a scale ranging from 0 to 27 points; higher scores indicate more severe depression. Change = (week 12 score - baseline score)

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change, From Baseline to Endpoint (12 Weeks) in the Total Score of the Patient Health Questionnaire (PHQ-9)	-2.2 score on a scale Standard Deviation 7.2	-2.5 score on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: baseline and twelve weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score).

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 PCS	4.5 score on a scale Standard Deviation 8.0	2.2 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: baseline and 12 weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

The SF-36 is a self-reported, validated questionnaire evaluating the general health quality in a scale ranging from 0 to 100 points; it evaluates 8 heath domains that yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better general health quality. Change = (week 12 score - baseline score).

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change, From Baseline to Endpoint (12 Weeks) in the Short-Form Health Survey SF-36 MCS	0.8 score on a scale Standard Deviation 12.4	1.9 score on a scale Standard Deviation 12.2

SECONDARY outcome

Timeframe: Baseline and 12 weeks after treatment

Population: Intent to Treat Population (all patients with at least a post-baseline evaluation)

Patients that showed at least a a 30% reduction in the score of the primary variable, i.e. the composite ccore of abdominal pain, abdominal bloating and metheorism each one measured in a 0-10 Visual Analog Scale, were considered as responders to treatment.

Outcome measures

Measure	VSL#3 n=53 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=53 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Number of Patients Considered as Responders to Treatment	27 participants	22 participants

SECONDARY outcome

Timeframe: Week 12 to week 16

Population: Patients considered as responders to treatment

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 16 score - week 12 score)

Outcome measures

Measure	VSL#3 n=27 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=22 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change From Week 12 to Week 16 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment	2.0 units on a scale Standard Deviation 5.2	1.7 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: Week 12 to week 20

Population: Patients considered as responders to treatment

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 20 score - week 12 score)

Outcome measures

Measure	VSL#3 n=27 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=22 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change From Week 12 to Week 20 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment	1.0 units on a scale Standard Deviation 3.7	3.4 units on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: Week 12 to week 24

Population: Patients considered as responders to treatment

Visual analogue scales are frequently used to evaluate subjective symptoms; they range from 0 (no symptom at all) to 10 (worst possible intensity of the symptom) points. In the present case the three most frequent abdominal symptoms reported by patients with fibromyalgia have been selected to compose the primary outcome variable. Total symptoms range was 0 to 30 points. Change = (week 24 score - week 12 score)

Outcome measures

Measure	VSL#3 n=27 Participants probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic 54 subjects	Placebo n=22 Participants matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo 56 subjects
Change From Week 12 to Week 24 (Follow-up Period) in the Composite Score of Abdominal Pain, Bloating and Metheorism Among Responders After Discontinuing the Study Treatment	1.3 units on a scale Standard Deviation 3.6	4.1 units on a scale Standard Deviation 5.5

Adverse Events

VSL#3

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	VSL#3 n=54 participants at risk probiotic VSL#3, 2 sachets b.i.d for 3 months VSL#3: sachets containing probiotic	Placebo n=56 participants at risk matched placebo, 2 sachets b.i.d for 3 months Placebo: sachets containing placebo
Gastrointestinal disorders abdominal distension	9.3% 5/54 • Number of events 5 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	1.8% 1/56 • Number of events 1 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders flatulence	9.3% 5/54 • Number of events 5 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	5.4% 3/56 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders abdominal pain	5.6% 3/54 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	5.4% 3/56 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders constipation	5.6% 3/54 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	7.1% 4/56 • Number of events 4 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders diarrhea	3.7% 2/54 • Number of events 2 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	0.00% 0/56 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders Vomiting	3.7% 2/54 • Number of events 2 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	0.00% 0/56 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
General disorders Disease worsening	3.7% 2/54 • Number of events 2 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	0.00% 0/56 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders Dispepsia	0.00% 0/54 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	5.4% 3/56 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Nervous system disorders Headache	0.00% 0/54 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	5.4% 3/56 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders Upper abdominal pain	0.00% 0/54 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	7.1% 4/56 • Number of events 4 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
General disorders Swelling	0.00% 0/54 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	3.6% 2/56 • Number of events 2 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Infections and infestations Influenza	0.00% 0/54 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	3.6% 2/56 • Number of events 2 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.
Gastrointestinal disorders Nausea	3.7% 2/54 • Number of events 2 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.	5.4% 3/56 • Number of events 3 • 12 weeks Adverse events were collected at each visit during the 12 weeks treatment period.

Additional Information

Dr. Elena Pita Calandre

Universidad de Granada

Phone: +34 958246291

Email: epita@ugr.es

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place