Participant flow:
A total of 254 accepted for eligibility, 54 were excluded and 100 healthy volunteers were randomly allocated to either the H. coagulans AO1167B or Placebo groups, with 50 individuals in each group. We lost to follow -up ,1 participants for personal reasons in the Placebo cohort
Baseline characteristics:
Distribution of cases according to demographics parameters
Demographic Variables H. coagulans AO1167B cohort (n=50) Placebo cohort (n=49) pValue
No % No %
Sex Female 31 62 31 63.3 0.896 a
Male 19 38 18 36.7
Age (years) Median ± SD 42.82±16.3 44.43 ± 14.74 1.0 b
BMI Median ± SD 23.20 ± 3.93 23.63± 4.17 0.764a
Outcome measures:
Primary Outcome Most participants (86.9%, n=86) did not experience any AEs (Table 6). Among them, 80% were in the probiotic group (n=40) and 93.9% were in the placebo group (n=46). There was a significant difference in the incidence of AEs between the treated and placebo groups (p = 0.04).
Secondary Outcome: The analysis of independent samples showed at baseline, only cholesterol levels were statistically significant (p = 0.020). By day 60, significant changes were observed in albumin (p < 0.01), total triglycerides (p = 0.031), and total bilirubin (p = 0.028) in both study groups. Significant differences were found at both baseline (ALAT p = 0.008, ASAT p < 0.01) and day 60 (ALAT p = 0.047, ASAT p < 0.01).
In the H. coagulans group, a student’s T-test for related samples showed significant decreases in creatinine (p = 0.032), albumin (p < 0.01), and MVC (p = 0.003). Significant increases were found in ASAT (p < 0.01), triglycerides (p = 0.001), total bilirubin (p = 0.010), MCHC (p < 0.01), and MPV (p = 0.040).
In the placebo group, significant increases were detected in urea (p = 0.012), GGT (p = 0.026), HTC (p = 0.001), and MVC (p < 0.01). Significant reductions were found in ALAT (p = 0.002), ASAT (p < 0.01), cholesterol (p < 0.01), total bilirubin (p = 0.002), and direct bilirubin (p = 0.001).
Bioimpedance measurements of weight and BMI showed no significant differences between study groups when analysed using the T-test for independent and related samples.
SF-36 questions (1, 6, 7, 11) on physical and emotional health status were analysed. Responses in both groups showed highly similar behaviours over time (Kappa ~1, p = 0.000), indicating strong agreement between initial and subsequent responses in both groups
Adverse events:
Most participants (86.9%, n=86) did not experience any AEs (Table 6). Among them, 80% were in the probiotic group (n=40) and 93.9% were in the placebo group (n=46). There was a significant difference in the incidence of AEs between the treated and placebo groups (p = 0.04).
Three AE cases occurred in the Placebo group: two reported looser stools, and the third, oedema, coincided with a new dengue infection, likely linked to the virus. Among those taking H. coagulans probiotic capsules, 10 individuals (20%) experienced mild AE. These included gastrointestinal pain or discomfort (n=2), gas (n=5), headache (n=1), and constipation (n=2).
The study comprised 62 females and 37 males. Most AE cases were reported by females (10/62) compared to males (3/37). One female (7%) from the Placebo group experienced moderate intensity AE coinciding with a dengue infection debut; others reported mild effects that lessened over treatment days without hindering daily activities.
Summary study:
Heyndrickxia coagulans, a lactic acid-producing bacterium, exhibits characteristics of both Lactobacillus and Bacillus genera. Clinical evidence suggests that Heyndrickxia coagulans strains have significant health benefits. This study aims to assess the safety of Heyndrickxia coagulans AO1167B as a potential probiotic supplement. Strain identification was confirmed via morphological and cultural techniques, and genomic characterization utilized 16S RNA and whole genome sequencing to identify antimicrobial resistance and virulence factors. Phenotypic analysis included disk diffusion tests for antimicrobial resistance. Cytotoxicity and haemolytic activity were assessed using Vero cells and erythrocytes. This phase I, double-blind, placebo-controlled clinical trial evaluated Heyndrickxia coagulans AO1167B through in vivo analyses Healthy adult volunteers were randomized into Heyndrickxia coagulans AO1167B and placebo groups, with a study duration of 60 days. Daily consumption of the test capsule or placebo was monitored through clinical and haematological evaluations, adverse event (AE) tracking, and health surveys. The genome of Heyndrickxia coagulans AO1167B showed no concerning features. Disk diffusion tests revealed no antimicrobial resistance. The strain exhibited no cytotoxic or haemolytic activity, indicating in vitro safety. No significant differences were observed in clinical or haematological parameters between the Heyndrickxia coagulans AO1167B and placebo groups. The most frequent adverse event was gas, which decreased over time. Heyndrickxia coagulans AO1167B is safe and well-tolerated for daily consumption over 60 days in healthy adults, supporting its potential for further probiotic development
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