The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers

NCT06937814 | Recruiting

• 1 other identifier: 2024-10-24-POSTL
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\[s\] it aims to answer \[is/are\]: Does Humiome ® Post LB improve bowel movements with self-reported GI issues? Participants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.

Conditions

GI Issues; Bowel Movements; Gastrointestinal Symptoms

Keywords

Bowel movements; Gastrointestinal symptoms; Bristol stool scale

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on bowel movements in healthy adult volunteers compared to Placebo

  To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on the difference in frequency of bowel movements as assessed by the Bowel Habits Diary (BHD) in healthy adult volunteers compared to Placebo adjusted on baseline at week 8 (Day 56; between group comparison).

  Day 0 to 56

Secondary Outcomes (15)

• The difference in frequency of bowel movements between Humiome® Post LB and Placebo

  Day 0 to 28

• The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline.

  Day 0 to 28

• The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline.

  Day 0 to 56

• The difference between Humiome® Post LB and Placebo in stool consistency.

  Day 0 to 28

• The difference between Humiome® Post LB and Placebo in stool consistency.

  Day 0 to 56

Other Outcomes (8)

• The difference between Humiome® Post LB and Placebo in GI symptoms

  Day 0 to 28

• The difference between Humiome® Post LB and Placebo in GI symptoms

  Day 0 to 56

• The difference after Humiome® Post LB and Placebo compared to baseline in GI symptoms

  Day 0 to 28

Study Arms (2)

Humiome® Post LB

EXPERIMENTAL

A postbiotic comprised of inactivated Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831), together referred to as Lactobacillus LB, and fermented culture medium.

Dietary Supplement: Humiome ® Post LB

Placebo

PLACEBO COMPARATOR

170 mg/day of micro-crystalline cellulose

Other: Placebo

Interventions

Humiome ® Post LB DIETARY_SUPPLEMENT

Participants will be instructed to take one capsule with a glass of water after the first meal of the day.

Humiome® Post LB

Placebo OTHER

Participants will be instructed to take one capsule with a glass of water after the first meal of the day.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent.
• Self-reported gastrointestinal issues defined as 10-20 bowel movements per week and a score of 5-6 for ≥20% of stools based on the BSS in the 2 weeks prior to baseline, as assessed by the Qualified Investigator (QI).
• Self-reported GI issues such as bloating, mild cramping, and urgency, as assessed by the QI.
• Be between 18 and 75 years of age, inclusive.
• Have a BMI of between 18.5 - 29.9 kg/m2, inclusive.
• Self-reported stable body weight (\<5% change) over the past 3 months.
• Be in general good health, as determined by the QI.
• Willing to avoid consuming prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal and anti-constipation medication until the end of the study (see Section 5.6).
• Willing to maintain current dietary habits and lifestyle, including level of physical activity, allowed medication/supplements habits for the duration of the study.
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)

You may not qualify if:

• Females who are pregnant, lactating or wish to become pregnant during the study.
• Are lactose intolerant or have any other hypersensitivity/allergy to any of the components of the test product.
• Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IV criteria, i.e. having recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
• Related to defecation.
• Associated with a change in frequency of stool.
• Associated with a change in form (appearance) of stool. Criteria need to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
• Have suffered from diarrhea (defined as ≥3 bowel movements per day and 6-7 on BSS) at any time two weeks prior to run-in, as assessed by the QI.
• Experience alarm features such as weight loss, rectal bleeding, or recent change in bowel habit (\<3 months), as assessed by the QI.
• Have taken antibiotics within the previous 2 months prior to the run-in period as assessed by QI (see Section 5.6.1).
• Unstable hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). Treatment on a stable dose of medication for at least 3 months will be considered by the QI.
• Known history of or ongoing HIV, hepatitis or clinically important, as judged by the QI, endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary conditions.
• Current or history of any significant diseases of the gastrointestinal tract (including but not limited to Crohn's disease, ulcerative colitis, celiacs disease, colectomy), as assessed by the QI.
• Have planned a major surgery during the study period as assessed by the QI.
• Have a history of drug and/or alcohol abuse in the past 12 months at the time of enrolment.
• Alcohol intake average of \>2 standard drinks per day as assessed by the QI

Sponsors & Collaborators

• KGK Science Inc.: collaborator
• dsm-firmenich Switzerland AG: lead

Study Sites (1)

KGK Science Inc.

London, Ontario, Canada

RECRUITING

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: June 16, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)