The clinical conditions specified in the observation groups are included in the study.
Conditions
Interventions
Group 1: Healthy children without known gastrointestinal complaints or diseases, diagnosed allergies, autoimmune diseases, lactose intolerance and other disorders of carbohydrate metabolism, diabetes,
Sponsors
IMD Institut für Medizinische Diagnostik Berlin-Potsdam GbR
Eligibility
Sex/Gender
All
Age
No minimum to 14 Years
Inclusion criteria
Inclusion criteria: Arm 1: - Age: 0 - 14 years - No gastrointestinal complaints Page 6 of 9 Version 2 - No food intolerances - No neurodermatitis - No asthma/chronic bronchitis - Less than 6 infections per year - No acute infection Arm 2: - Age: 0 - 14 years - No neurodermatitis Page 7 of 9 Version 2 - No asthma/ chronic bronchitis - Less than 6 infections per year - No acute infection - Recurrent gastrointestinal complaints (abdominal pain, meteorism, abdominal cramps, colic) or one of the following diagnosed gastrointestinal diseases: K50, Crohn's disease; K51, Ulcerative colitis; K52, Other non-infectious gastroenteritis and colitis; K58, Irritable bowel syndrome; K59, Other functional bowel disorders; K63, Other diseases of the intestine; K90, Intestinal malabsorption; K92, Other diseases of the digestive system; R10, Abdominal and pelvic pain; R14, Flatulence and related conditions; K92, Other diseases of the digestive system Arm 3: - Age: 0 - 14 years - No acute infection - The following diagnosed allergic diseases: J30.1, Allergic rhinopathy due to pollen; J45, Bronchial asthma; L20, Atopic eczema; J30.4, Allergic rhinopathy - The following diagnosed autoimmune diseases: E10, Diabetes mellitus, type 1; M08, Juvenile arthritis; K90.0, Coeliac disease
Exclusion criteria
Exclusion criteria: Arm 1: - Diagnosed gastrointestinal diseases: K21, Gastroesophageal reflux disease; K29, Gastritis and duodenitis; K50, Crohn's disease; K51, Ulcerative colitis; K52, Other non-infectious gastroenteritis and colitis; K58, Irritable bowel syndrome; K59, Other functional bowel disorders; K63, Other diseases of the intestine; K90, Intestinal malabsorption; K92, Other diseases of the digestive system; R10, Abdominal and pelvic pain; R14, Flatulence and related conditions; Q43. 1, Hirschsprung's disease; P54.2, Neonatal rectal haemorrhage; P54.3, Other neonatal gastrointestinal haemorrhage; K92, Other diseases of the digestive system; A00-A09, Infectious intestinal diseases - Diagnosed autoimmune diseases: E10, Diabetes mellitus, type 1; M08, Juvenile arthritis; K90.0, Coeliac disease - Diagnosed allergic diseases: J30.1, Allergic rhinopathy due to pollen; J45, Bronchial asthma; L20, Atopic [endogenous] eczema; J30.4, Allergic rhinopathy, unspecified; L23, Allergic contact dermatitis; L27, Dermatitis due to orally, enterally or parenterally ingested substances (incl. cow's milk allergy); K52.2, Allergic and alimentary gastroenteritis and colitis; T78.4, Allergy, unspecified - Other diagnosed diseases: E11, Type 2 diabetes mellitus; J06, Acute infections of multiple or unspecified upper respiratory tract sites localisations of the upper respiratory tract; E73, Lactose intolerance; E74, Other disorders of carbohydrate metabolism - Faecal calprotectin elevated (according to age-related reference values specified by the manufacturer) reference values specified by the manufacturer) - Intake of medication: Antibiotics in the last 8 weeks, allergy medication, immunosuppressants, probiotics, metformin, proton pump inhibitors Arm 2: - Diagnosed autoimmune diseases: E10, diabetes mellitus, type 1; M08, juvenile arthritis; K90.0, celiac disease - Diagnosed allergic diseases: J30.1, Allergic rhinopathy due to pollen; J45, Bronchial asthma; L20, Atopic [endogenous] eczema; J30.4, Allergic rhinopathy, unspecified; L23, Allergic contact dermatitis; L27, Dermatitis due to orally, enterally or parenterally ingested substances (incl. cow's milk allergy); K52.2, Allergic and alimentary gastroenteritis and colitis; T78.4, Allergy, unspecified - Other diagnosed diseases: E11, Type 2 diabetes mellitus; J06, Acute infections of multiple or unspecified upper respiratory tract sites localisations of the upper respiratory tract - Intake of medication: Antibiotics in the last 8 weeks, allergy medication, immunosuppressants, probiotics, metformin, proton pump inhibitors Arm 3: - Diagnosed gastrointestinal diseases: K21, Gastroesophageal reflux disease; K29, Gastritis and duodenitis; K50, Crohn's disease; K51, Ulcerative colitis; K52, Other non-infectious gastroenteritis and colitis; K58, Irritable bowel syndrome; K59, Other functional bowel disorders; K63, Other diseases of the intestine; K90, Intestinal malabsorption; K92, Other diseases of the digestive system; R10, Abdominal and pelvic pain; R14, Flatulence and related conditions; Q43. 1, Hirschsprung disease; P54.2, Rectal haemorrhage in newborn; P54.3, Other gastrointestinal haemorrhage in newborn; K92, Other diseases of the digestive system; A00-A09, Infectious intestinal diseases - Other diagnosed diseases: E11, Type 2 diabetes mellitus; J06, Acute infections of multiple or unspecified sites of the upper respiratory tract localisations of the upper respiratory tract; E73, Lactose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No classical endpoint can be defined. The first aim of this study is to investigate diagnostic markers established for adults, which can be measured in stool samples, in a cohort of healthy children. The data will be used to test whether the same reference values could be used in children as in adults. The second aim of the study is to carry out the aforementioned tests in children with diagnosed chronic inflammatory bowel disease or irritable bowel syndrome and in children with allergies or autoimmune diseases. These data will be used to assess whether the investigated stool markers are suitable for the diagnosis of dysbiosis, inflammation of the intestinal mucosa or reduced digestive performance in paediatric patients, in line with their use in adults. | — |
Countries
Germany
Contacts
Public ContactChristiane Kupsch
IMD Institut für Medizinische Diagnostik Berlin-Potsdam GbR
Outcome results
None listed