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Effect of digestive enzymes supplement on bacterial diversity in patients with chronic pancreatitis

Role of pancreatic enzyme replacement therapy on gut microbiome, metabolome and body response in patients with chronic pancreatitis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/10/028302
Enrollment
90
Registered
2020-10-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K861- Other chronic pancreatitis

Interventions

Intervention1: Pancreatic enzyme replacement therapy: Patients with chronic pancreatitis with pancreatic exocrine insufficiency will receive pancreatic enzyme replacement therapy (amylase 18,000 â?? 2

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. 18 to 65 years 2. Idiopathic chronic pancreatitis with and without pancreatic exocrine insufficiency 3. Participants giving the consent Healthy controls: will be the relative of the patient who reside in same environment as patients 1. Aged 18 to 65 years 2. No pregnancy 3. No calorie restriction or other special diets 4. No known allergy 5. Not on medical treatment influencing intestinal function

Exclusion criteria

Exclusion criteria: 1.Medical history of immune deficiency, atopy, asthma, celiac disease, colon cancer, HIV, inflammatory bowel disease, irritable bowel syndrome, gastroenteritis, necrotizing enterocolitis, rheumatoid arthritis, metabolic or liver disease. 2.Pregnancy 3.Medical treatment influencing intestinal function. 4.Subjects received antibiotics or probiotics in last 4 weeks

Design outcomes

Primary

MeasureTime frame
1.Compare gut microbiome; and fecal, serum and tissue metabolome in patients of chronic pancreatitis with and without pancreatic exocrine insufficiency with healthy controls 2.Change in gut microbiome; and fecal, serum and tissue metabolome after pancreatic enzyme replacement therapy in patients with chronic pancreatitis with exocrine pancreatic insufficiencyTimepoint: 0 and 3 months—

Secondary

MeasureTime frame
1.Change in level of inflammatory cytokines pre- and post- pancreatic enzyme replacement therapy 2.Changes in gut-barrier function pre- and post- pancreatic enzyme replacement therapy 3.Change in anthropometry, body composition and quality of life Timepoint: 0 and 3 months—

Countries

India

Contacts

Public ContactDeepak Gunjan

All India Institute of Medical Sciences, Delhi

drdg_01@rediffmail.com01126546579

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026