A randomized, double-blind, placebo-controlled, parallel study to evaluate the effect of DigeSEB Super PB on gastrointestinal health in adult population.
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- 1. Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (to be filled daily from screening to Day30 plus or minus day 2).
Study Overview
Brief Summary
The relevance of this study is to evaluate the common yet neglected aspect of having a digestive system disorder and how it affects one’s quality of life. Pancreatic insufficiency, lactose intolerance, and irritable bowel syndrome (IBS), conditions that prevent the secretion of certain enzymes, result in symptoms such as heartburn, bloating, constipation, and diarrhea. Although these symptoms are commonly experienced, many people disregard timely intervention leading to residual discomfort in the gastrointestinal system. The current treatment options rely heavily on medication, which may deter individuals from using them due to the severe side effects. Additionally, these treatments are not suitable for extended use. Therefore, there are acceptable substitutes that are safer to use and can be taken for producing effective results that further improve digestive activity. A combination of enzyme and probiotic supplementation is one such technique that has the potential to improve digestion. This enhances nutrient absorption, relief from nervous system symptoms, and maintain an overall improvement of gastrointestinal issues. This study seeks to assess the effectiveness of DigeSEB Super PB formulation with the addition of digestive enzymes and probiotic supplements in relieving digestive symptoms among adults with mild to moderate digestive distress. By assessing the strength and efficacy of this formulation, the study contributes toward the development of safe and effective interventions that are not involving drugs targeting digestive health. This method would be advantageous for addressing issues of impaired digestion and exacerbating existing gastrointestinal disorders.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects having (self-reported) dyspepsia.
- •Subject has to fill in GSRS questionnaire form (GSRS will be collected during the screening and two days prior to consent, provided the subject has reported any symptoms). The person who reports at least one or more (mild or moderate) symptoms (out of- nausea, vomiting, heartburn, abdominal pain, headache, breathless, diarrhea or constipation) at least 2 days will be included in study.
- •Subjects who have mild to moderate symptoms (for mild- 1 to 3, moderate.
- •4 to 6, and severe.
- •Normotensive (seated, resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg).
- •Refrain from caffeine and exercise for 24 hours prior to each visit, and fast for 10 hours prior to visit 3 and
- •Following stable and consistent diet regimen.
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
Exclusion Criteria
- •Pregnant and lactating female.
- •Subjects with BMI greater than or equal to 35
- •Subjects who are chronic smokers and alcoholics
- •Subject having known allergy to the ingredients in the test product.
- •Subject having a history of or currently has any gastrointestinal disease or disorder or any inflammatory bowel condition such as Gastroesophageal reflux disease (GERD), Cohns disease, short bowel, ulcerative colitis, or irritable bowel syndrome (IBS).
- •Subjects with long-standing or worsening symptoms during the run-in period.
- •Subject has a history of bariatric surgery at any time before the Screening Visit.
- •Subject has a history of any surgery in the past 3 months.
- •Subject on medications for diarrhea, constipation, heart burn or any other gastrointestinal problems.
- •Subject currently taking laxatives or has taken laxatives within the 30 days prior to screening or enrollment.
- •Subject currently taking antibiotics (or any drug that significantly interferes with bacterial flora) or has taken antibiotics within the 60 days prior to screening or enrollment.
- •Subject currently taking or has in the past 30 days used GI related probiotics or prebiotics or any digestive enzymes [prescription or over the counter (OTC)].
Outcomes
Primary Outcomes
1. Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (to be filled daily from screening to Day30 plus or minus day 2).
Time Frame: 30 days
2. Day 1 and Day 30 (Detailed Assessment)- VAS scale for each symptom (bloating, gas, nausea, heartburn) to be recorded at 30 min, 60 min, 90 min, and 120 min after a meal
Time Frame: 30 days
3. Day 2 to Day 29 (Daily Assessment)- VAS scale for each symptom (bloating, gas, nausea, heartburn, etc.) to be recorded once daily at a consistent time of day (e.g. after the main meal)
Time Frame: 30 days
4. DQLQ questionnaire (Weekly assessment from Day 1 to 30 plus or minus 2)
Time Frame: 30 days
5. VAS for pain, stool consistency and frequency (Every day assessment from Day 1 to 30 plus or minus 2)
Time Frame: 30 days
6. SF-36 questionnaire (Assessment on Day 1, Day 15 and Day 30 plus or minus 2)
Time Frame: 30 days
7. Postprandial Hunger and satiety scale (Every day assessment from Day 1 to 30, 2hrs after consuming lunch)
Time Frame: 30 days
Secondary Outcomes
- 1. Measure bloating or waist circumference after meal consumption (assessment at 30 min, 60 min, 90 min(and 120 min after meal consumption on Day 1 and Day 30))
- 4. Product tolerability(a. Tolerability to investigation product (Questionnaire to be filled daily throughout the study duration).)
Investigators
Dr Sanjay Kumar
Gastrocare Multi Speciality Hospital