The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome

NCT04422327 | Completed Phase 1 DMC

• 1 other identifier: AFCRO-079
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to assess the impact of consumption of COMBO, a combination product of two Bifidobacterium longum strains, on stress, mood and bowel symptoms in adults with Irritable Bowel Syndrome (IBS).

Conditions

IBS - Irritable Bowel Syndrome; Depression, Anxiety

Keywords

Combination of probiotics; Bifidobacterium longum 35624®; Bifidobacterium longum 1714™; depression; anxiety; bowel symptoms; Irritable Bowel Syndrome (IBS); Sleep quality; Cognition; Safety

Outcome Measures

Primary Outcomes (1)

• Change in stress and mood, assessed by Hospital Anxiety and Depression Scale (HADS) scores

  HADS gives HADS-A and HADS-D scores; minimum score for each is 0, maximum score is 21. Higher scores indicate worse stress/mood.

  Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.

Secondary Outcomes (17)

• Change in Subject Global Assessment (SGA) of IBS symptoms, assessed by weekly eDiary

  Assessed weekly from baseline to 8 weeks post supplement intake.

• Change in Subject Global Assessment (SGA) of abdominal pain/discomfort, assessed by weekly eDiary

  Assessed weekly from baseline to 8 weeks post supplement intake.

• Change in IBS-Symptom Severity Score (IBS-SSS)

  Assessed at baseline, 4 and 8 weeks of supplement intake, and 4 and 8 weeks post supplement intake.

• Change in stool frequency, assessed by daily eDiary

  Assessed daily from baseline to 8 weeks post supplement intake.

• Change in stool consistency (Bristol Stool Scale), assessed by daily eDiary

  Assessed daily from baseline to 8 weeks post supplement intake.

Study Arms (1)

Probiotic capsule

EXPERIMENTAL

The participants consume one probiotic capsule a day for 8 weeks

Dietary Supplement: Probiotic capsule

Interventions

Probiotic capsule DIETARY_SUPPLEMENT

Each probiotic capsule contains 5 x 10\^8 CFU B. longum 35624® and 5 x 10\^8 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsule will be supplied by PrecisionBiotics Ltd.

Probiotic capsule

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be considered eligible for enrolment into the study, subjects must;
• Be able to give written informed consent,
• Be a Caucasian female, between 18 and 55 years of age,
• Subject has Irritable Bowel Syndrome according to the Rome III Diagnostic Criteria:
• Recurrent abdominal pain or discomfort\*\* at least 3 days/month in the last 3 months associated with two or more of the following:
• i. Improvement with defecation
• ii. Onset associated with a change in frequency of stool
• iii. Onset associated with a change in form (appearance) of stool
• Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
• \*\* "Discomfort" means an uncomfortable sensation not described as pain.
• Subjects agree to complete symptom diaries and return completed diaries at all sessions,
• Subjects with mild to moderate score (8-14) on the HADS-A and/or HADS-D questionnaire, Subjects will be excluded if there is greater than 1 point difference from the screening to baseline scores,
• Be willing to refrain from taking any dietary supplements or other fermented foods that contain live bacteria during the study,
• Be willing to refrain from taking any medications or preparations used in the therapy of IBS (herbal, dietary supplements, homeopathic preparations, etc.) during the study and from 4-weeks before the baseline visit,
• Be willing to refrain from probiotic use 4 weeks before the baseline visit,

You may not qualify if:

• Subjects will be excluded from the study if they meet any of the below criteria;
• Are less than 18 and greater than 55 years of age at the time of consent,
• Females are pregnant, lactating or wish to become pregnant during the study. Female subject is currently either of:
• non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or any female who is surgically sterilized (via documented hysterectomy or bilateral tubal ligation). (For purposes of this study, postmenopausal is defined as one year without menses), OR
• child bearing potential, the subject is eligible to enter and participate in this study if she is not lactating and has a negative urine pregnancy test at the screening visit, visit 2 and upon completion of the study at visit 7. The subject must also agree to one of the following methods of contraception:
• i. Complete abstinence from intercourse two weeks prior to administration of study drug, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study medication in cases where subject discontinues the study prematurely. (Subjects utilizing this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit.) or,
• ii. has a male sexual partner who is surgically sterilized prior to the Screen Visit and is the only male sexual partner for that subject or,
• iii. sexual partner(s) is/are exclusively female or,
• iv. Oral contraceptives (either combined or progestogen only) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm. (Women of child-bearing potential using an oral contraceptive in combination with a double-barrier method of contraception are required to continue to use this form of contraception for 1 week following discontinuation of study medication).
• v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical barrier (e.g. male condom, female diaphragm). The subject must be using this method for at least 1 week following the end of the study or,
• vi. Use of any intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1% per year. The subject must have the device inserted at least 2 weeks prior to the first Screen Visit, throughout the study, and 2 weeks following the end of the study,
• Are hypersensitive to any of the components of the test product,
• Consumption of Alflorex probiotic for 6 months,
• Consumption of any type of yoghurts or probiotic-containing products in the 4 weeks prior to the baseline visit,
• Subjects who have been on antibiotics during the past month,

Sponsors & Collaborators

• PrecisionBiotics Group Ltd.: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials Ltd.

Cork, Ireland

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Eileen Murphy, PhD

  PrecisionBiotics Group Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study, with intervention period followed by follow-up (wash out) period.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 9, 2020
• Study Start: September 20, 2017
• Primary Completion: February 12, 2018
• Study Completion: February 12, 2018
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)