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Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial.

ABSTRACT: BACKGROUND:Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota-gut-brain axis. However, the exact mechanisms are not fully identified. Recent evidence suggests the modulatory effect of synbiotics on gut microbiota and the contribution of these agents in ameliorating symptoms of many psychiatric diseases. To date, no randomized controlled trial has been performed to establish the feasibility and efficacy of this intervention targeting the reduction of impulsivity and compulsivity. We hypothesize that supplementation with synbiotics may be an effective treatment in adults with high levels of impulsivity and/or compulsivity. METHODS/DESIGN:This is a prospective, multicenter, double-blind, randomized controlled trial with two arms: treatment with a synbiotic formula versus placebo treatment. The primary outcome is the response rate at the end of the placebo-controlled phase (response defined as a Clinical Global Impression-Improvement Scale score of 1 or 2?=?very much improved or much improved, plus a reduction in the Affective Reactivity Index total score of at least 30% compared with baseline). A total of 180 participants with highly impulsive behavior and a diagnosis of attention deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder, aged 18-65?years old, will be screened at three study centers. Secondary outcome measures, including changes in general psychopathology, ADHD symptoms, neurocognitive function, somatic parameters, physical activity, nutritional intake, and health-related quality of life, will be explored at assessments before, during, and at the end of the intervention. The effect of the intervention on genetics, microbiota, and several blood biomarkers will also be assessed. Gastrointestinal symptoms and somatic complaints will additionally be explored at 1-week follow-up. DISCUSSION:This is the first randomized controlled trial to determine the effects of supplementation with synbiotics on reducing impulsive and compulsive behavior. This clinical trial can contribute to explaining the mechanisms involved in the crosstalk between the intestinal microbiome and the brain. If effects can be established by reducing impulsive and compulsive behavior, new cost-effective treatments might become available to these patients. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03495375. Registered on 26 February 2018.

SUBMITTER: Arteaga-Henriquez G

PROVIDER: S-EPMC7014653 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial.

Arteaga-Henríquez Gara G Rosales-Ortiz Silvia Karina SK Arias-Vásquez Alejandro A Bitter Istvan I Ginsberg Ylva Y Ibañez-Jimenez Pol P Kilencz Tünde T Lavebratt Catharina C Matura Silke S Reif Andreas A Rethelyi Janos J Richarte Vanesa V Rommelse Nanda N Siegl Anne A Ramos-Quiroga J Antoni JA

Trials 20200211 1

<h4>Background</h4>Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota-gut-brain axis. However, the exact mechanisms are not fully identified. Recent evidence suggests the modulatory effect of synbiotics on gut microbiota and the contribution of these agents in ameliorating symptoms o ...[more]

PMID: 32046750

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Project description:Background There is no clear evidence-based medicine that points to the most effective drug treatments for the common cold. In view of its ability to relieve symptoms and shorten the disease course, as well as its minimal side effects, traditional Chinese medicine (TCM) has been widely used to treat the common cold. However, there is a lack of strong evidence to support the clinical efficacy of TCM. This study aimed to evaluate the efficacy and safety of Ganduqing granules in the treatment of the common cold based on the network pharmacology analysis. Methods In this multicenter, randomized, double-blind, placebo-controlled trial, 60 eligible subjects will be randomly assigned to either the intervention group or the placebo group. The intervention group will be treated with Ganduqing granules, while the placebo group will be treated with placebo. After 5 days of intervention, the efficacy and safety of Ganduqing granules in the treatment of the common cold will be observed. The primary outcome is the time to clearance of all symptoms. The secondary outcomes included the levels of IL-6, TNF-α, SOD, and MDA in the peripheral blood, time to disappearance of primary symptoms and secondary symptoms, clinical symptom remission rate, and change in TCM syndrome score. Results Sixty participants completed the study. Ganduqing granules showed a greater effect on the time to clearance of all symptoms (P < 0.0001), nasal discharge (P=0.0124), fatigue and lack of strength (P=0.0138), dryness of the pharynx (P < 0.0001), pharyngalgia or dysphagia (P < 0.0001), and expectoration (P < 0.0431) compared with the placebo group. Participants in the intervention group had a greater decrease of IL-6 levels compared with the placebo group (P < 0.007); similar results were observed for the SOD (P < 0.033). However, the change in TNF-α and MDA levels in the intervention group was not significantly different from the placebo group. In addition, participants in the intervention group had a greater decrease of TCM syndrome score compared with the placebo group (P < 0.040). Conclusion Ganduqing granules could improve common cold symptoms, shorten the disease course, attenuated inflammation and oxidative stress, and provided objective evidence for the efficacy and safety of a Chinese herbal medicine in treating the common cold.

Project description:BACKGROUND:Our study aimed to determine the effect of probiotic consumption containing six viable microorganisms of 30?×?1010?cfu Lactobacillus and Bifidobacteria strains for six months on clinical outcomes and inflammatory cytokines (TNF-?, IFN-?, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22) in patients with colorectal cancer. METHODS:Fifty-two patients with colorectal cancer were randomized at four weeks after surgery to receive either a placebo (n?=?25) or 30 billion colony-forming unit (CFU) of a mixture of six viable strains including 107?mg of Lactobacillus acidophilus BCMC® 12,130, Lactobacillus lactis BCMC® 12,451, Lactobacillus casei subsp BCMC® 12,313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129 (n?=?27). Patients were instructed to take the product orally twice daily for six months. Infection status, diarrhea or hospital admission were recorded throughout the study. Blood was taken pre- and post-intervention to measure TNF-?, IFN-?, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 using ELISA multiplex kit. RESULTS:The majority of cases (~?70%) were in Duke's C colorectal cancer for both groups. No surgical infection occurred and no antibiotics were required. Chemotherapy induced diarrhea was observed in both groups. Significant reduction in the level of pro-inflammatory cytokine, TNF-?, IL-6, IL-10, IL-12, IL-17A, IL-17C and IL-22 were observed in CRC patients who received probiotics as compared to pre-treatment level (P?<?0.05). However, there was no significant difference in the IFN-? in both groups. CONCLUSIONS:We have shown that probiotics containing six viable microorganisms of Lactobacillus and Bifidobacteria strains are safe to be consumed at four weeks after surgery in colorectal cancer patients and have reduced pro-inflammatory cytokines (except for IFN-gamma). Probiotic may modify intestinal microenvironment resulting in a decline in pro-inflammatory cytokines. TRIAL REGISTRATION:NCT03782428; retrospectively registered on 20th December 2018.

Project description:Misfolded aggregated proteins and neuroinflammation significantly contribute to amyotrophic lateral sclerosis (ALS) pathogenesis, hence representing therapeutic targets to modify disease expression. Rapamycin inhibits mechanistic target of Rapamycin (mTOR) pathway and enhances autophagy with demonstrated beneficial effects in neurodegeneration in cell line and animal models, improving phenotype in SQSTM1 zebrafish, in Drosophila model of ALS-TDP, and in the TDP43 mouse model, in which it reduced neuronal loss and TDP43 inclusions. Rapamycin also expands regulatory T lymphocytes (Treg) and increased Treg levels are associated with slow progression in ALS patients.Therefore, we planned a randomized clinical trial testing Rapamycin treatment in ALS patients.RAP-ALS is a phase II randomized, double-blind, placebo-controlled, multicenter (8 ALS centers in Italy), clinical trial. The primary aim is to assess whether Rapamycin administration increases Tregs number in treated patients compared with control arm. Secondary aims include the assessment of safety and tolerability of Rapamycin in patients with ALS; the minimum dosage to have Rapamycin in cerebrospinal fluid; changes in immunological (activation and homing of T, B, NK cell subpopulations) and inflammatory markers, and on mTOR downstream pathway (S6RP phosphorylation); clinical activity (ALS Functional Rating Scale-Revised, survival, forced vital capacity); and quality of life (ALSAQ40 scale).Rapamycin potentially targets mechanisms at play in ALS (i.e., autophagy and neuroinflammation), with promising preclinical studies. It is an already approved drug, with known pharmacokinetics, already available and therefore with significant possibility of rapid translation to daily clinics. Findings will provide reliable data for further potential trials.The study protocol was approved by the Ethics Committee of Azienda Ospedaliero Universitaria of Modena and by the Ethics Committees of participating centers (Eudract n. 2016-002399-28) based on the Helsinki declaration.

Dataset Information

Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial.

Publications

Treating impulsivity with probiotics in adults (PROBIA): study protocol of a multicenter, double-blind, randomized, placebo-controlled trial.

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