An interventional study of Assisted Infant Toilet Training in Infantile Colic, Constipation - Functional and Bladder Dysfunction, sponsored by Dalarna County Council, Sweden. Active, not recruiting at 6 sites in Sweden. Open to participants aged Up to 2 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-21.
Sponsored by Dalarna County Council, Sweden · Not applicable, Interventional, and Prevention
The overall purpose is to assess whether assisted infant toilet training during the first year of life can prevent functional gastrointestinal and urinary tract disorders up to 4 year of age. Healthy Swedish children will be randomized to start assisted infant toilet training at 0-2 months of age or at 10-11 months of age.
The toilet training process will be described including mother-to-infant attachment and parental stress.
The mastery of toilet training is an important developmental milestone for children and parents. The age at which children start toilet training has increased during the last decades in the Western world. 50 years ago most children were out of nappies by 1,5 years of age. Today, wearing nappies by 3-4 years of age is considered normal. Meanwhile an increase in functional gastrointestinal and urinary tract disorders and toileting problems is reported by health care professionals.
A randomized multicenter intervention study is conducted at Child Health Care Centers in Sweden to investigate whether assisted infant toilet training initiated during the first year of life can prevent functional bowel and bladder disorders.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 293 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →Dalarna County Council, Sweden is the lead sponsor of 28 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Parents to Children randomized to group A will be instructed in how infant toilet training is performed by the investigators. They receive a book in Swedish concerning infant toilet training and a brief summary of the book made by the investigators. The parents are encouraged to begin infant toilet training as early as possible, 0-2 months of age The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.
Behavioral: Assisted Infant Toilet Training
Parents to Children randomized to group B will be instructed in how infant toilet training is performed by the co-workers doing the ultrasound measure of rectal diameter at 9 months. They receive a book in Swedish concerning infant toilet training and a brief summary of it made by the investigators. They start infant toilet training at the age of 10-11 months. The definition of adherence to the intervention is to perform at least one attempt a day of infant toilet training (without the requirement of a successful outcome) on at least 5 out of 7 days per week.
Behavioral: Assisted Infant Toilet Training
The parents learn to sensitively respond to the child's routines and signals of elimination needs.The child's ability to convey the need for bowel and bladder evacuation is enhanced through responsive interaction so that a kind of assisted dryness is developed. The infant is held "squatting" over a potty or basin, while older children sit on the potty.
Also known as: Elimination Communication
Prevalence of functional constipation
Functional constipation, measured with validated questionnaires according to the ROME IV criteria
Time frame: Up to 9 months of age
Prevalence of infant dyschezia
Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Time frame: Up to 9 months of age
Prevalence of infant colic
Infant colic measured with validated questionnaires according to the ROME IV criteria, including a prospective 24h infant behavioral diary when infant colic is suspected
Time frame: Up to 5 months of age
Prevalence of functional constipation
Functional constipation, measured with validated questionnaires according to the ROME IV criteria.
Time frame: Up to 4 years of age
Prevalence of gastrointestinal symptoms
Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro)
Time frame: At 4 years of age
Prevalence of stool toileting refusal
Stool toileting refusal, measured with validated questionnaire
Time frame: At 4 years of age
Prevalence of bladder dysfunction
Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions.
Time frame: Up to 4 years of age.
Infant-to-mother attachment
Infant-to-mother attachment, measured with Maternal Postnatal Attachment Scale (MPAS). It contains 19 issues, questions are scored 1-5. Total score is calculated by adding scores on all issues. Scale range for total score is 19-95. High score indicates higher mother-to-infant attachment.
Time frame: Up to 9 months of age
Parental stress
Parental stress, measured with Swedish Parental Stress Questionnaire (SPSQ). It contains 34 issues each scoring 1-5. Total score is calculated as an average on answers (1-5) on all issues. Scale range for total score is 34-170. High score indicates higher parental stress.
Time frame: Up to 2,5 years of age
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dalarna County Council, Sweden