In this study LactoSpore® will be compared with an inert substance in relieving symptoms of functional gas and bloating.
- Conditions
- Health Condition 1: R198- Other specified symptoms and signsinvolving the digestive system and abdomen
- Registration Number
- CTRI/2019/06/019617
- Lead Sponsor
- Sami Labs Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Male or female subjects ranging in age from 18 to 65 years (both inclusive) diagnosed as having gastro intestinal disorders and based on the medical history record will be included in the study by the Investigator.
2 Subjects with Small intestinal Bacterial Overgrowth with symptoms of abdominal discomfort, gas & bloating, distension etc.
3 Fulfilling Rome IV Diagnostic Criteria for Functional Abdominal Bloating/Distension. Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
a)Recurrent bloating and/or distention occurring, on average, at least 1 day per week; abdominal bloating and/or distention predominates over other symptoms.
4 Willingness to follow the protocol requirement as evidenced by written, informed consent.
5 Willingness to complete subject diaries and study questionnaires.
6 Agree not to use any medication (prescription and over the counter), including vitamins, proteins and minerals supplement during the course of this study.
7 Recurrent feeling of bloating or visible distension at least 3 days/month in the last 3 months.
8 Agree not to use any dairy product during the course of this study.
9 Willing to avoid the pre-biotic and pro-biotic food supplements, laxatives and foods having laxative effects during the study.
10 Gastrointestinal Symptom Rating Scale score >=5.
11 Able to give written informed consent.
12 Avoid high fibre diet
13 Willing to come for regular follow-up visits.
1 Sufficient criteria for a diagnosis of functional dyspepsia or other functional GI disorder.
2 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
3 Significant abnormal findings as determined by screening, history, physical examination, vital signs (blood pressure, pulse rate, respiration rate) hematology, urinalysis.
4 Subjects with Gastrointestinal disorders or other digestive problems such as Crohnâ??s disease, short bowel, ulcerative colitis, constipation or Lactose Intolerance.
5 Subjects using GI medication to control the function of the gut, such as anti-spasmodic, pro-kinetic agents or laxatives.
6 Subjects who were under antibiotic medication past 21 days.
7 History or presence of significant alcoholism or drug abuse in the past one year.
8 Participation in a clinical study during the preceding 6 months.
9 History of malignancy or other serious disease.
10 Any contraindication to blood sampling.
11 Smoking or Consumption of tobacco products and Alcohol.
12 Subjects allergic to certain dietary supplements in related to Gastrointestinal Disorder.
13 Unexplained weight loss less than 3 months.
14 Blood or blood products donated in past 30 days prior to study supplement administration.
15 Female subjects on pregnancy and lactating women.
16 Female subjects with pre menstrual syndrome with gas and bloating and subjects with menopause.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method