Study Evaluating the Safety and Tolerability of a Probioitc

NCT05044949 | Completed

• 1 other identifier: CSUB0196
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

The rationale for the current study is to initially evaluate the safety and tolerability of a novel strain of the probiotic Limosilactobacillus reuteri (L. reuteri) in healthy volunteers.

Conditions

Healthy Volunteers; Tolerability; Safety

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of treatment emergency adverse events (safety and tolerability).

  The product to be investigated is a probiotic product and not an investigational medicinal product. However, the procedures for monitoring, collecting and reporting of AEs will be the same as for an investigational medicinal product. Vital signs, systolic and diastolic blood pressure and pulse will be measured. Vital signs will be judged as normal, abnormal, not clinically significant or abnormal, clinically significant. Safety laboratory parameters, blood samples for analysis of clinical chemistry and haematology will be analysed by routine analytical methods. Urine drug screen and urine pregnancy test will be performed. Abnormal values assessed by the Investigator as clinically significant will be reported as AEs. If an abnormal value is associated with corresponding clinical signs or symptoms, the sign/symptoms should be reported as the AE.

  28 days

Secondary Outcomes (1)

• To evaluate tolerability in terms of gastrointestinal symptoms

  28 days

Study Arms (3)

Low dose L reuteri capsules

ACTIVE COMPARATOR

Subjects will be asked to consume 2 capsules with high dose L reuteri per day in 28 days.

Other: Probiotic

High dose L reuteri capsules

ACTIVE COMPARATOR

Subjects will be asked to consume 2 capsules with a low dose L reuteri per day in 28 days.

Other: Probiotic

Placebo capsules

PLACEBO COMPARATOR

Subjects will be asked to consume 2 capsules with placebo powder per day in 28 days.

Other: Placebo

Interventions

Probiotic OTHER

The study product is a probiotic strain

High dose L reuteri capsules; Low dose L reuteri capsules

Placebo OTHER

The study product is a placebo to the probiotic strain

Placebo capsules

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to give written informed consent for participation in the study.
• Healthy male or female subject aged 18-65 years inclusive.
• Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2.
• Clinically normal medical history, physical findings, vital signs, and laboratory values at the time of screening, as judged by the Investigator.
• Female subjects of child bearing potential must practice abstinence (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of \< 1% to prevent pregnancy (combined \[oestrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal contraception associated with inhibition of ovulation \[oral, injectable, implantable\], intrauterine device \[IUD\]or intrauterine hormone-releasing system \[IUS\]) from at least 4 weeks prior to dose to 4 weeks after last dose. Female subjects of non-childbearing potential are defined as pre-menopausal females who are sterilised (tubal ligation or permanent bilateral occlusion of fallopian tubes); or post-menopausal defined as 12 months of amenorrhea (in questionable cases a blood sample with simultaneous detection of follicle stimulating hormone \[FSH\] 25-140 IE/L is confirmatory).

You may not qualify if:

• History of or ongoing clinically significant disease that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the IP.
• Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
• Any planned major surgery within the duration of the study.
• Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibodies or HIV.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to Lactobacillus probiotic treatment.
• History of, or ongoing GI disorder, including but not limited to irritable bowel syndrome (IBS), constipation, loose stools or excess gas which, in the discretion of the Investigator, may influence the results or the subject's ability to participate in the study.
• Regular use of any prescribed or non-prescribed medication including antacids and analgesics within 2 weeks prior to the first administration of IP, at the discretion of the Investigator.
• Any use of antibiotics (except local treatment, e.g., eye drops) within 2 weeks prior to the first administration of IP.
• Regular use of supplements, i.e., tablets, drops, capsules etc, that contain L. reuteri or any other probiotics within 2 weeks prior to the first administration of IP.
• Regular intake of foods or beverages that contain L. reuteri or any other probiotics, e.g., yoghurt and other probiotic dairy products, within 2 weeks prior to the first administration of IP. Foods that contain microorganisms, live or dead, that do not confer any health benefit on the host, e.g., regular yoghurt, are allowed.
• Planned treatment or treatment with an investigational drug within 3 months prior to Day 1. Subjects consented and screened but not dosed in previous clinical studies are not excluded.
• Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than 3 times per week is allowed before the screening visit.
• Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP. Drugs of abuse and alcohol will also be screened during the study (refer to Section 9.6.1).
• History of alcohol abuse or excessive intake of alcohol, as judged by the Investigator.

Sponsors & Collaborators

• BioGaia AB: lead

Study Sites (2)

Clinical Trial Consultants AB

Uppsala, 752 37, Sweden

Location

CTC, Dag Hammarskjölds väg 10B

Uppsala, 75237, Sweden

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Study Officials

• Erik Rein-Hedin, MD

  CTC Clinical Trial Consultants AB,Dag Hammarskjolds v- 10B, SE-752 37 Uppsala, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind and the allocation of treatments will not be disclosed until clean file has been declared and the database has been locked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-blind, randomised, placebo-controlled, parallel-group study

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 16, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 20, 2022
• Last Updated: February 11, 2022

Record last verified: 2022-01

Locations

SE (2)