Effect of probiotics, &lt;i&gt;Bifidobacterium bifidum&lt;/i&gt; G9-1, on gastrointestinal symptoms in patients with type 2 diabetes mellitus: study protocol for open-label, single-arm, exploratory research trial (Big STAR study)

Hashimoto, Yoshitaka; Nakajima, Harushi; Hata, Shinnosuke; Miyoshi, Tomoki; Hosomi, Yukako; Majima, Susumu; Nakanishi, Naoko; Senmaru, Takafumi; Osaka, Takafumi; Okada, Hiroshi; Ushigome, Emi; Hamaguchi, Masahide; Asano, Mai; Yamazaki, Masahiro; Fukui, Michiaki

doi:10.3164/jcbn.20-100

Cited by 5 publications

(5 citation statements)

References 18 publications

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“…This study was an open-label, single-arm, exploratory study (Effect of Probiotics, Bifidobacteria, on Gastrointestinal Symptoms in Patients with Type 2 Diabetes Mellitus; Open-label, Single-Arm, Exploratory Research [Big STAR study]). The detailed protocol of the Big STAR study has been published previously 18 .…”

Section: Study Design Ethics Approval and Consent To Participatementioning

confidence: 99%

“…Based on these findings, we hypothesized that probiotic bifidobacteria could improve gastrointestinal complications, especially constipation and diarrhea, in type 2 diabetes patients treated with metformin; however, there have been no previous studies examining this. Therefore, we carried out the present study to investigate the effects of the probiotic BBG9-1 on the gastrointestinal complications in type 2 diabetes patients treated with metformin 18 .…”

Section: Introductionmentioning

confidence: 99%

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Effects of probiotic Bifidobacterium bifidum G9‐1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open‐label, single‐arm, exploratory research trial

Hata

Nakajima

Hashimoto

et al. 2021

J of Diabetes Invest

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Aims/Introduction: Metformin is associated with the risk of gastrointestinal complications, and probiotic Bifidobacterium bifidum G9-1 (BBG9-1) can improve the symptoms of diarrhea. This study aimed to clarify the effects of probiotic BBG9-1 on the gastrointestinal symptoms of type 2 diabetes mellitus patients using metformin. Materials and methods:In this open-label single-arm exploratory study, 40 patients (mean age 64.0 -9.4 years) were given probiotic BBG9-1 for 10 weeks. Changes in the gastrointestinal symptom rating scale total score, which was the primary end-point, gastrointestinal symptom rating scale subscale scores, glycated hemoglobin levels and gut microbiota after the administration of probiotic BBG9-1 were evaluated by the Student's t-test. Results: The gastrointestinal symptom rating scale total score significantly improved (from 2.02 -0.51 to 1.59 -0.43, change, -0.43 -0.49, P < 0.001). Furthermore, all gastrointestinal symptom rating scale subscale scores, including diarrhea (from 2.32 -1.14 to 1.89 -0.99, change, -0.42 -0.95, P = 0.007) and constipation (from 3.00 -1.16 to 2.20 -1.07, change, -0.80 -1.19, P < 0.001), scores also significantly improved. However, the glycated hemoglobin levels did not change (from 7.0 -0.7 to 7.0 -0.6%, change, 0.0 -0.4, P = 0.91). The relative abundance of the genus Sutterella decreased by the use of probiotic BBG9-1 (from 0.011 -0.009 to 0.008 -0.006, change, -0.003 -0.006, P = 0.002). Conclusions: Type 2 diabetes mellitus patients treated with metformin showed significant improvement in all gastrointestinal symptom rating scores after using probiotic BBG9-1 without changing the glucose control. This study showed the potential usefulness of probiotic BBG9-1 for improving gastrointestinal symptoms, including constipation and diarrhea, in type 2 diabetes mellitus patients treated with metformin.

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Section: Study Design Ethics Approval and Consent To Participatementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effects of probiotic Bifidobacterium bifidum G9‐1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open‐label, single‐arm, exploratory research trial

Hata

Nakajima

Hashimoto

et al. 2021

J of Diabetes Invest

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“…In a sub-analysis of a previous study [ 15 , 18 ], BBG9-1 oral administration changed the total GSRS score by -0.441 ± 0.499. In the non-treatment period, the change in the total GSRS score was -0.197 ± 0.314.…”

Section: Materials and Methods: Participants Interventions And Outcomesmentioning

confidence: 82%

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study)

Hashimoto,

Kobayashi,

Kitagawa

et al. 2024

PLoS ONE

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Background This randomized, parallel-group study aims to investigate the effects of the probiotic Bifidobacterium bifidum G9-1 (BBG9-1) on the symptoms of diarrhea or constipation in patients with type 2 diabetes mellitus (T2DM). Methods This study will examine 100 patients with T2DM who suffering from symptoms of diarrhea or constipation. Eligible patients will be randomly assigned 1:1 to two groups (group A, BBG9-1 group; group B, control group), after the baseline examination. Patients assigned to group A will receive probiotic BBG9-1 oral administration along with their current treatment for 12 weeks, and patients assigned to group B will continue the current treatment for 12 weeks without probiotic BBG9-1 oral administration. Subsequently, examinations similar to the baseline examinations will be performed. The primary endpoint will be a change in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to week 12. Secondary endpoints will include the following: change and percent change in parameters such as GSRS subdomain scores, fecal properties/Bristol stool form scale, defecation frequency, biomarkers, gut microbiota, and macronutrients and factors that affect GSRS total score or constipation/diarrhea subdomain scores from baseline to week 12. Discussion The results of this study will clarify the utility of probiotic BBG9-1 in the treatment of diarrhea or constipation in patients with T2DM. Trial registration jRCTs051220127.

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“…Given the novelty of the topic, studies conducted on human are fewer than animal studies. However, there are several ongoing studies that address the issue [101,102]. One of the first clinical trials that analyzed the effects of adding a prebiotic blend to metformin showed the combination to be significantly better than placebo plus metformin in alleviating the gastrointestinal symptoms associated with metformin intake, and also in lowering FPG levels [103].…”

Section: Human Studiesmentioning

confidence: 99%

Enhancing Metformin Effects by Adding Gut Microbiota Modulators to Ameliorate the Metabolic Status of Obese, Insulin-Resistant Hosts

Seicaru

Ilie

Cătinean

et al. 2022

JGLD

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Obesity is a systemic disease and represents one of the leading causes of death worldwide by constitutingthe main risk factor for a series of non-communicable diseases such as type 2 diabetes mellitus (T2DM),cardiovascular diseases and dyslipidemia. Lifestyle interventions have been attempting to prevent T2DM andobesity but are difficult to maintain by most patients. However, the recent focus on the intestinal microbiotaand its important role in the host’s metabolism provides a new key for improving metabolic health. Modulatingthe composition of the gut microbiota was proposed as a method to manage these metabolic diseases andmost frequently this is undertaken by using probiotics, prebiotics or synbiotics. Furthermore, the action ofmetformin, the most commonly prescribed drug for treating T2DM, is mediated in part by the gut microbiota,although this interplay may also be responsible for the frequent gastrointestinal adverse effects of metformin.Thus, adding a gut microbiota modulator (GMM), such as probiotics or prebiotics, to metformin therapy couldamplify its anti-diabetic effects, while decreasing its adverse reactions. This review summarizes the varioustherapies that are used to shift the composition of the microbiome and their efficacy in alleviating metabolicparameters, it assesses the interaction between metformin and the gut microbiota, and it evaluates the existingclinical and preclinical studies that analyze the potential synergy of a combined metformin-GMM therapy.

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Effect of probiotics, <i>Bifidobacterium bifidum</i> G9-1, on gastrointestinal symptoms in patients with type 2 diabetes mellitus: study protocol for open-label, single-arm, exploratory research trial (Big STAR study)

Cited by 5 publications

References 18 publications

Effects of probiotic Bifidobacterium bifidum G9‐1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open‐label, single‐arm, exploratory research trial

Effects of probiotic Bifidobacterium bifidum G9‐1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open‐label, single‐arm, exploratory research trial

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study)

Enhancing Metformin Effects by Adding Gut Microbiota Modulators to Ameliorate the Metabolic Status of Obese, Insulin-Resistant Hosts

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