Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicentre, Randomised, Double-Blind, Placebo Controlled, Crossover Trial On The Efficacy Of A Mixture Of Three Bifidobacteria In Children With Abdominal Pain-Associated Functional Gastrointestinal Disorders
Brief Summary: Abdominal pain (AP)-associated functional gastrointestinal disorders (FGIDs), particularly Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), are common in pediatrics, and no safe and effective treatment is available. Although probiotics have shown promising results in adults, few studies have been published in children. The Bifidobacterium Infantis, Bifidobacterium Breve and Bifidobacterium Longum are the most important beneficial bacteria in children and represent 95% of the total bacterial population in the intestine of breastfed infant.

Objectives: 1) To evaluate the effect of oral administration of a mixture of Bifidobacteria on the improvement of frequency and intensity of AP in children with FD and IBS. 2) To evaluate the effect of oral administration of a mixture of Bifidobacteria on quality of life in children with FD and IBS.


Options:
A: Inclusion Criteria:

* Age 4-18years;
* Diagnosis of FD and IBS pain according to the Rome III criteria
* All parents or legal tutors must sign an informed consent document indicating their awareness of the investigational nature of this study.

Exclusion Criteria:

* Taking any other type of probiotic in the 2 months prior to enrollment
* Presence of intestinal motility disorders
* Presence of any other significant medical condition
* Presence of previous abdominal surgery
* Inability or unwillingness to give informed consent
B: Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Any chronic or organic illness
C: Inclusion Criteria:

* Children with functional abdominal pain (age 4-18 years)
* Children with chronic constipation (age 2-18 years)

Exclusion Criteria:

* Immunodeficiency
* Receiving probiotic and/or prebiotic products 7 days prior to enrolment
* Neoplasms
* Chronic disorders
* Presence of "red flags":

  * Weight loss of more than 10%
  * Growth retardation or growth failure
  * Extraintestinal symptoms (fever, rash, joint pain, aphthae, affection of the urinary system)
  * Frequent vomiting
  * Abnormalities in laboratory findings (anemia, elevated ESR)
  * Abnormalities in clinical findings (organomegaly, perianal disease)
D: Inclusion Criteria:

* Patients were considered for study inclusion, if they were 4 - 12 years of age and had if they had a pain history of at least 12 weeks (which need not be consecutive) in the preceding 12 months suggestive for IBS or FAP with no structural or metabolic abnormalities to explain the symptoms and according to the Rome II diagnostic criteria valid at the time of the design of the study.
* IBS was diagnosed in presence of an abdominal discomfort or pain with at least two of three features:

  * relieved with defecation
  * onset associated with a change in stool frequency
  * onset associated with a change in the form (appearance) of the stool.
* FAP was diagnosed in presence of symptoms of
* Continuous (nearly continuous) abdominal pain
* No or only occasional relation of pain with physiological events (e.g. eating, menses)
* Some loss of daily functioning
* The pain is not feigned (e.g. malingering)
* The patient has insufficient criteria for other functional gastrointestinal disorders that would explain the abdominal pain.

Exclusion Criteria:

* Known concomitant psychiatric, neurological, metabolic, hepatic, renal, infectious, haematological, cardiovascular and pulmonary disease
* Treatment with antibiotics/probiotics in the last 2 months
* A pain history suggestive for functional dyspepsia or aerophagia or abdominal migrain
* Growth failure
* Gastroparesis
* Gastrointestinal obstructions/stricture
* Any disease that may affect bowel motility such as diabetes, connective disease or poorly controlled hypo/hyperthyrodism
* Previous abdominal surgery.

Answer: A