Trial Outcomes & Findings for Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome (NCT NCT01886781)

Results Overview

The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

81 participants

Primary outcome timeframe

Total trial period 12 weeks

Results posted on

2014-09-29

Participant Flow

Patients were recruited at a private gastroenterology clinic in Port Elizabeth, South Africa between January 2011- June 2013,

Run-in phase of 1-2 weeks, then an 8 week treatment phase followed by a 2 week wash out period.

Participant milestones

Participant milestones
Measure	Lactobacillus Plantarum 299v Treatment Lactobacillus plantarum 299v	Placebo Controls Crytalline cellulose powder
Overall Study STARTED	54	27
Overall Study COMPLETED	40	25
Overall Study NOT COMPLETED	14	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactobacillus Plantarum 299v Treatment Lactobacillus plantarum 299v	Placebo Controls Crytalline cellulose powder
Overall Study Protocol Violation	5	0
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	5	0
Overall Study Withdrawal by Subject	2	1
Overall Study Worsening of symptoms	1	1

Baseline Characteristics

Effect of Lactobacillus Plantarum 299v on Symptoms of Irritable Bowel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactobacillus Plantarum 299v n=54 Participants Treatment Lactobacillus plantarum 299v	Placebo n=27 Participants Controls Crytalline cellulose powder	Total n=81 Participants Total of all reporting groups
Age, Continuous	48.15 years STANDARD_DEVIATION 13.48 • n=5 Participants	47.27 years STANDARD_DEVIATION 12.15 • n=7 Participants	47.86 years STANDARD_DEVIATION 13.03 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	27 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment South Africa	54 participants n=5 Participants	27 participants n=7 Participants	81 participants n=5 Participants
Body Mass Index	28.83 kg/m^2 STANDARD_DEVIATION 7.12 • n=5 Participants	28.88 kg/m^2 STANDARD_DEVIATION 7.74 • n=7 Participants	28.85 kg/m^2 STANDARD_DEVIATION 7.32 • n=5 Participants
Duration of IBS (years)	9.58 years STANDARD_DEVIATION 10.32 • n=5 Participants	10.05 years STANDARD_DEVIATION 9.36 • n=7 Participants	9.74 years STANDARD_DEVIATION 10 • n=5 Participants

PRIMARY outcome

Timeframe: Total trial period 12 weeks

The clinical severity of the IBS symptoms (pain and distension) was evaluated by the Francis Severity Score questionnaire (Francis 1997). The questionnaire is a validated tools for use in IBS. The severity score contained five questions, each given a value from 0 (no symptoms) to 100 (most severe) for measuring the severity and frequency of abdominal pain. The sum of scores of these questions was considered the severity score, with a maximum possible score of 500

Outcome measures

Outcome measures
Measure	Lactobacillus Plantarum 299v n=40 Participants Treatment Lactobacillus plantarum 299v	Placebo n=25 Participants Controls Crytalline cellulose powder
A Change in Abdominal Pain Severity Baseline	259.66 units on a scale Standard Deviation 106.90	256.04 units on a scale Standard Deviation 104.27
A Change in Abdominal Pain Severity End of treatment at week 8	199.13 units on a scale Standard Deviation 119.70	201.98 units on a scale Standard Deviation 97.44
A Change in Abdominal Pain Severity Change	60.53 units on a scale Standard Deviation 12.8	54.06 units on a scale Standard Deviation 6.83

Adverse Events

Lactobacillus Plantarum 299v

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lactobacillus Plantarum 299v n=54 participants at risk Treatment Lactobacillus plantarum 299v	Placebo n=27 participants at risk Controls Crytalline cellulose powder
Reproductive system and breast disorders Severe rash	1.9% 1/54	0.00% 0/27

Other adverse events

Adverse event data not reported

Additional Information

Cheryl Stevenson

University of Stellenbosch, South Africa

Phone: 0827514411

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place