Placebo control study of lansoprazole for the treatment of functional dyspepsia in children
- Conditions
- Functional dyspepsia,
- Registration Number
- CTRI/2023/04/052031
- Lead Sponsor
- Fourrts pharmaceutical company
- Brief Summary
•Functional dyspepsia is one of the common functional gastrointestinal disorders with prevalence of 10-20% .
•Impaired gastric accommodation reflex, food allergy, delayed gastric emptying, post viral gastroparesis are some of the causes attributed to the etiology
•Genetic predisposition and psychiatric comorbidity may also play role to some extent .
DIAGNOSTIC CRITERIA [ROME IV]-
FUNCTIONAL DYSPEPSIA -
Must include one or more of the following bothersome symptoms at least 4 times a month for at least 2 months prior to diagnosis:
•Postprandial fullness
•Early satiation
•Epigastric pain or burning not associated with defecation
•After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
Within FD(Functional dyspepsia) the following subtypes are now adopted:
•H2a1. Postprandial distress syndrome includes bothersome postprandial fullness or early satiation which prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching.
•H2a2. Epigastric pain syndrome which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component, (b) commonly induced or relieved by ingestion of a meal but may occur while fasting.
Research questions -
•Is 4 week treatment regime of lansoprazole more effective than placebo in alleviating the symptoms of functional dyspepsia in children ?
PRIMARY OBJECTIVE –
To compare the effect of lansoprazole vs placebo on participants for complete relief of epigastric pain and postprandial distress during the last 3 days of 4 week treatment
•
SECONDARY OBJECTIVE –
•Relief from other gastrointestinal symptoms like :nausea ,upper abdominal bloating , excessive belching , heartburn at day 7 , 14 and 28
• Evaluate the participants at day 7 and 14 for complete relief of epigastric pain and postprandial distress i.e. early improvement
Inclusion criteria -•Inclusion is based on the Rome IV criteria for functional dyspepsia [age 4 to 18 years ]
Exclusion criteria -•Patient already on treatment with Proton pump inhibitors (PPI) /H2RA, Prokinetics ,NSAIDS or within 1 week of study commencement
•Previous Gastrointestinal surgery and diseases (e.g. – ulcerative colitis, crohn’s disease)
•Chronic systemic illness (liver,heart,renal diseases)
•History of H. Pylori infection and treatment in last 6 months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 120
- FUNCTIONAL DYSPEPSIA (Roams 4 criteria).
- Must include one or more of the following bothersome symptoms at least 4 times a month for at least 2 months prior to diagnosis: Postprandial fullness Early satiation Epigastric pain or burning not associated with defecation After appropriate evaluation, the symptoms cannot be fully explained by another medical condition Within FD(Functional dyspepsia) the following subtypes are now adopted: H2a1.  Postprandial distress syndrome includes bothersome postprandial fullness or early satiation which prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching. H2a2.  Epigastric pain syndrome which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component, (b) commonly induced or relieved by ingestion of a meal but may occur while fasting.
- 1.Patient already on treatment with Proton pump inhibitors (PPI) /H2RA, Prokinetics ,NSAIDS or within 1 week of study commencement 2.Previous Gastrointestinal surgery and diseases (e.g. – ulcerative colitis, crohn’s disease) 3.Chronic systemic illness (liver,heart,renal diseases) 4.History of H.
- Pylori infection and treatment in last 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of lansoprazole vs placebo on participants for complete relief of epigastric pain and postprandial distress during the last 3 days of 4 week treatment 28 days
- Secondary Outcome Measures
Name Time Method 1).Relief from other gastrointestinal symptoms like : nausea ,upper abdominal bloating , excessive belching , heartburn at day 7 , 14 and 28
Trial Locations
- Locations (1)
Eras Lucknow medical college
🇮🇳Lucknow, UTTAR PRADESH, India
Eras Lucknow medical college🇮🇳Lucknow, UTTAR PRADESH, IndiaMohammad Saif ChaudharyPrincipal investigator8090596570drsaifchaudhary@gmail.com