Health Condition 1: null- Major Depressive Disorder in diarrhoea predominant irritable bowel syndrome Health Condition 2: F339- Major depressive disorder, recurrent, unspecified
Conditions
Interventions
Intervention1: LactoSpore® - containing Bacillus coagulans MTCC 5856 - 2 billion spores.
: One tablet of LactoSpore to be taken orally along with standard treatment for 90 days.
Control Intervention1
Sponsors
Sami labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and/or female subjects ranging in age between 20 to 65 years. 2. Fulfilling Rome III Diagnostic Criteria for Functional IBS (Functional Diarrhoea). Criterion fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis a) Recurrent abdominal pain or discomfort (uncomfortable sensation not described as pain) at least 3 days/month in the last 3 months associated with two or more of the following: i. Improvement with defecation ii. Onset associated with a change in frequency of stool iii. Onset associated with a change in form (appearance) of stool b) Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months c) Loose (mushy) or watery stools without pain occurring in at least 75% of stools 3.Willingness to follow the protocol requirement as evidenced by written, informed consent. Newly diagnosed, IBS patients mild to moderate in severity with possible sleep, pain and dementia associated co morbidities. 4.Willingness to complete subject diaries and study questionnaires. 5.Agree not to use any medication (prescription and over the counter), including vitamins and minerals, during the course of this study. 6.Agree not to use any yogurt during the course of this study. 7.Subjects whose blood chemistries are within a normal range or not considered clinically significant if outside the normal range. 8.Subjectâ??s assurance that they have not taken antibiotics or other drugs whose primary site of action is in the GIT for a period up to 1 month prior to the start of the study. 9.Willing to come for regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. 2.Significant abnormal findings as determined by baseline history, physical examination,vital signs(blood pressure, pulse rate, respiration rate) hematology, serum chemistry,urinalysis. 3.History or presence of significant alcoholism or drug abuse in the past one year. 4.Any medical or surgical conditions, which might significantly, interfere with the gastro intestinal tract, liver, kidneys, and/or blood-forming organs. 5.History of cardiovascular, renal, hepatic, asthma, glaucoma, pulmonary, neurologic,metabolic or psychiatric disease. 6.Participation in a clinical study during the preceding 90 days. 7.History of malignancy or other serious disease. 8.Any contraindication to blood sampling. 9.Smoking or Consumption of tobacco products. 10.Blood or blood products donated in past 30 days prior to study supplement administration. 11.Female subjects on pregnancy and lactating women. 12.Prior surgical therapy for obesity. 13.Patients using yogurt in their daily meal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1]Improvement in depression as assessed by the change in Hamilton Rating Scale for Depression (HAM-D) 2]Change in Montgomery-Asberg Depression Rating Scale (MADRS) 3]Sleep quality & depressive symptom severity using 11-item Center for Epidemiological Studies â??Depression Scale (CES-D) 4]Irritable bowel syndrome quality of life questionnaire (IBS-QOL)Timepoint: 1]Hamilton Rating Scale for Depression - Visit 1, Visit 2, Visit 3 & Visit 4 2]Montgomery-Asberg Depression Rating Scale - Visit 1, Visit 2, Visit 3 & Visit 4 3]Center for Epidemiological Studies Depression Scale - Visit 1, Visit 2, Visit 3 & Visit 4 4]Irritable bowel syndrome quality of life questionnaire - Visit 1, Visit 2, Visit 3 & Visit 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1]Change in Clinical Global Impression- Improvement rating Scale 2]Change in Clinical Global Impression Severity rating Scale 3]Dementia â?? Revised Memory & Behaviour Problem Checklist 4]Change in Gastrointestinal Discomfort Questionnaire 5]Modified Epworth Sleepiness Scale as subjective testTimepoint: 1]Clinical Global Impression- Improvement rating Scale (Day 0,Day 30,Day 60 and Day 90) 2]Clinical Global Impression Severity rating Scale (Day 0,Day 30,Day 60 and Day 90) 3]Dementia â?? Revised Memory & Behaviour Problem Checklist(Day ),Day 30,Day 60 and Day 90) 4]Change in Gastrointestinal Discomfort Questionnaire(Day ),Day 30,Day 60 and Day 90) 5]Modified Epworth Sleepiness Scale as subjective test (Day 0,Day 30,Day 60 and Day 90) | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
ClinWorld Private Limited
Outcome results
None listed