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Hyderabad, India

Ratna Sudha M.,Unique Biotech Ltd | Maurya A.K.,Government LTMG Hospital
Beneficial Microbes | Year: 2012

Bacterial vaginosis (BV) is a common condition affecting millions of women annually and is characterised by a reduction in native lactobacilli. Antimicrobial therapy used to cure the disease is often found to be ineffective. We postulate that the potential probiotic capsule UB-01BV might be efficient in the treatment of BV. In the present study, 30 Indian women diagnosed with BV presenting symptoms such as white discharge, pH greater than 4.7, increased discharge, odour, colour of discharge and pruritus were included. All subjects were assigned to receive two potential probiotic capsules UB-01BV a day for 7 days. At the end of the treatment all subjects showed significant (P<0.001) positive response as revealed by a reduction in vaginosis symptoms. Therefore, the results of the present study provide the first preliminary evidence that the potential probiotic capsule UB-01BV can exert a significant reduction in vaginal infection. © 2012 Wageningen Academic Publishers. Source


Ratna Sudha M.,Unique Biotech Ltd | Bhonagiri S.,Medipoint Hospital Pvt. Ltd. Pune | Asin Kumar M.,Government LTMG Hospital
Beneficial Microbes | Year: 2013

This study was conducted to evaluate the anti-diarrhoeal activity of Bacillus clausii strain UBBC 07 in patients suffering from acute diarrhoea. A total of 27 patients (average age of 35.44±8.08 years) with acute diarrhoea were included in a prospective, Phase II clinical study after informed consent and ethical committee approval. The criteria included for all subjects were ≥3 loose stool motions within 24 hours and for more than 7 days. All patients were assigned to receive one capsule of B. clausii strain UBBC-07 (containing 2×109 cfu) two times a day for a period of 10 days. Efficacy assessment of duration of diarrhoea, frequency of defecation, abdominal pain and stool consistency were tested on days 1, 3, 6 and 10. Safety was evaluated by assessing the incidence and type of adverse effects such as increase in blood pressure and pulse rate, physical examination and clinical laboratory tests, i.e. complete blood count, serum glutamic pyruvic transaminase, serum creatinine, and stool examination and microscopy, on day 1 and day 10. The results of this study clearly showed that the mean duration of diarrhoea decreased from 34.81±4.69 to 9.26±3.05 (P<0.0001) min per day, the frequency of defecation also decreased from 6.96±1.05 to 1.78±0.50 (P<0.0001) times per day, abdominal pain decreased from 3.22±0.93 (severe) to 0.74±0.71 (absent) (P<0.0001), and stool consistency improved from 3.93±0.38 (watery) to 1.22±0.42 (soft) (P<0.0001). No significant change in safety parameters were observed during treatment. This study shows that the B. clausii strain UBBC-07 can potentially be effective in alleviating the symptoms of diarrhoea without causing any adverse effects. © 2013 Wageningen Academic Publishers. Source


Ratna Sudha M.,Unique Biotech Ltd | Bhonagiri S.,Medipoint Hospital Pvt. Ltd. | Asin Kumar M.,Government LTMG Hospital
Beneficial Microbes | Year: 2012

This study was conducted to evaluate the efficacy and safety of Saccharomyces boulardii strain Unique 28 in patients suffering from acute diarrhoea. A total of 25 patients (average age 30.72±4.38 years) with symptoms of acute diarrhoea (≥3 loose motion in last 24 hours for <7 days) were included upon informed consent and ethical committee approval. All subjects were assigned to consume S. boulardii strain Unique 28 (5×109 cfu/capsule) twice a day for a duration of 10 days. Primary outcome measures such as duration of diarrhoea, frequency of defaecation, abdominal pain and consistency of stool were analysed on day 1, 3, 6 and 10 of the study. Secondary outcome measures were evaluated by assessment of incidence and type of adverse events (blood pressure and pulse rate), physical examination and clinical laboratory tests (complete blood count, glutamic-pyruvic transaminase, serum creatinine, stool examination and microscopy and these tests were performed on day 1 and 10 of the study. The results of the present study indicate that the mean duration of diarrhoea decreased from 34.20±4.25 to 9.40±3.00 (P<0.0001) min per day, frequency of defaecation decreased from 7.04±0.84 to 1.76±0.52 (P<0.0001) times a day, abdominal pain decreased from 3.28±1.06 (severe) to 0.72±0.50 (absent) (P<0.0001) and consistency of stool improved from 3.80±0.50 (watery) to 1.32±0.47 (soft) (P<0.0001). In addition, no significant changes in safety parameters were observed during treatment. Therefore, the present study concludes that S. boulardii strain Unique-28 might be useful in alleviating the symptoms of diarrhoea without any adverse effects. © 2012 Wageningen Academic Publishers. Source


Sudha R.M.,Unique Biotech Ltd | Bhonagiri S.,Medipoint Hospital Pvt. Ltd.
International Journal of Probiotics and Prebiotics | Year: 2012

The objective of this study was to evaluate the efficacy and safety of Bacillus coagulans strain Unique IS-2 in the treatment of patients with acute diarrhea. To this end, a total of 28 patients with acute diarrhea were included in a prospective, phase II clinical study upon obtaining consent and ethical committee approval. The trial was performed on patients of both sexes between 18 to 55 years of age and having > 3 loose motions in last 24 hours for less than7 Days. All patients were assigned to receive capsule (containing 2 billion CFU of Bacillus coagulans strain Unique IS-2) two times daily for a duration of 10 days. Efficacy was evaluated by assessment of duration of diarrhea (in minutes) frequency of defecation (times per day), abdominal pain (3=severe; 2=moderate; l=mild; 0=absent) and consistency of stool (1=normal, 2=hard, 3= semi liquid, and 4=loose). Safety aspects of capsule were evaluated by assessment of incidence, type of adverse events, physical examination, and clinical laboratory test values (CBC, SGPT, serum creatinine, stool routine and microscopy). Concomitant medications including rescue medications were monitored throughout the study. Efficacy assessment for duration of diarrhea, frequency of defecation, abdominal pain, consistency of stool and fever was done on 1, 3, 6 and 10 days. Mean values for, duration of diarrhea decreased from 35.60 ß 5.46 to 3.52 ß 2.69 min per day, frequency of defecation was decreased from 7.96 ß 3.89 to 0.76 ß 0.60 times per day, abdominal pain decreased from 3.16 ß 0.99 to 0.36 ß 0.49 and consistency of stool improved from 3.84 ß 0.55 to 1.00 ß 0.00. No significant change in safety parameters was observed during treatment. This trial demonstrates that utilization of B. coagulans Unique IS-2 strain is efficient and safe to treat the patients with acute diarrhea. Source


Sudha M.R.,Unique Biotech Ltd | Sawant P.,LTM Medical College and Hospital
Beneficial Microbes | Year: 2011

The objective of this research was to study the efficacy and safety of capsule 'UB03' to treat patients with Irritable Bowel Syndrome (IBS). Thirty patients with Rome II IBS were assigned to receive capsule 'UB03' (10 billion lyophilised bacteria and yeast/capsule produced by Unique Biotech Limited, India) twice daily for 90 days. Assessment of IBS was carried out according with Rome II criteria and their severity for 90 days of treatment with an interval of 30 days. Complete haemogram, serum glutamic pyruvic transaminase, serum creatinine were performed as a part of safety evaluation at the time of inclusion and after 90 days of treatment. There was significant improvement in frequency of defecation (23%), consistency of stool, abdominal discomfort, bloating and flatulence. However, there was no significant change in abdominal pain and mucus in stool. This trial demonstrates that the consumption of capsule 'UB03' containing potential probiotic strains is found to be effective and safe for the treatment of patients with IBS. © 2011 Wageningen Academic Publishers. Source

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