Infantile ColicBABITTNCT04082689
Bowel And Bladder Function in Infant Toilet Training
A study testing Assisted Infant Toilet Training in people with Infantile Colic and Constipation - Functional, run by Dalarna County Council, Sweden at 6 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Infantile Colic, Constipation - Functional, Bladder Dysfunction
- What is being tested?
- Assisted Infant Toilet Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 6 sitesSweden
- Study dates
- 18 Apr 2019to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full-term infant (born at gestational week 37+0 to 41+6)
Who cannot join
- Infants with malformations or disorders that may affect the gastrointestinal or urinary tract in any relevant way
- Infants born small for gestational age (SGA), < - 2 standard deviation
- Parents with insufficient understanding of the Swedish language
- Infants older than 2 months, 1 week and 6 days at inclusion
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites
Unicare vårdcentral Borlänge
Borlänge, Dalarna County, 78460
Vårdcentral Kvarnsveden
Borlänge, Dalarna County
Elsborgs Familjecentral
Falun, Dalarna County, 79151
Falu Vårdcentral
Falun, Dalarna County, 79170
Familjecentralen Bönan
Leksand, Dalarna County, 79331
Barnavårdscentral Mora
Mora, Dalarna County, 79230
About this study
Official title: Bowel And Bladder Function in Infant Toilet Training- a Randomized Intervention Study to Investigate the Efficacy of Assisted Infant Toilet Training on Preventing Functional Gastrointestinal and Urinary Tract Disorders up to 4 Years of Age
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.
Read the detailed description
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.
- Being tested
- Assisted Infant Toilet Training
- Keywords
- Colic, Constipation, Bladder dysfunction, Toilet training
- Medical subject headings
- Colic, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted Infant Toilet TrainingBehavioural
Also called Elimination Communication
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.
| Study group | Role | What they receive |
|---|---|---|
| Assisted Infant Toilet Training-Group A | Active comparator | 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. Receives: Behavioral: Assisted Infant Toilet Training |
| Assisted Infant Toilet Training- Group B | Active comparator | 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. Receives: Behavioral: Assisted Infant Toilet Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of functional constipation
Functional constipation, measured with validated questionnaires according to the ROME IV criteria
Measured: Up to 9 months of age
Prevalence of infant dyschezia
Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Measured: 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
Measured: Up to 5 months of age
Secondary outcomes (4)
Prevalence of functional constipation
Functional constipation, measured with validated questionnaires according to the ROME IV criteria.
Measured: Up to 4 years of age
Prevalence of gastrointestinal symptoms
Gastrointestinal symptoms, measured with Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module (PedsQL Gastro)
Measured: At 4 years of age
Prevalence of stool toileting refusal
Stool toileting refusal, measured with validated questionnaire
Measured: At 4 years of age
Prevalence of bladder dysfunction
Bladder dysfunction, measured with validated questionnaires according to International Childrens Continence Society (ICCS) definitions.
Measured: Up to 4 years of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start18 Apr 2019
- Primary completion30 Jun 2022
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial (RCT) where one group of children who begin assisted infant toilet training at age 0-2 months (group A) is compared to a group of children who begin assisted infant toilet training at 10-11 months (group B).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalarna County Council, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Clinical Research Dalarna, Sweden, Örebro University, Sweden, Göteborg University
- Responsible party
- Principal investigator, Barbro Hedin Skogman, Dalarna County Council, Sweden
- Investigators
- Barbro Hedin Skogman, assoc. prof., Study director, Dalarna County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082689
- Sponsor's protocol ID
- BABITT-01
- Acronym
- BABITT
- Status last verified
- Feb 2025
- First submitted
- 12 Jun 2019
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilsson T, Leijon A, LoMartire R, De la Calle Dahlstedt S, Sillen U, Hellstrom AL, Skogman BH. Assisted infant toilet training and the prevalence of functional gastrointestinal disorders up to the age of 9 months: a randomised, controlled trial. Arch Dis Child. 2026 Feb 19;111(3):238-244. doi: 10.1136/archdischild-2025-328792.
PubMed 41249012Nilsson T, Leijon A, Sillen U, Hellstrom AL, Skogman BH. Bowel and bladder function in infant toilet training (BABITT) - protocol for a randomized, two-armed intervention study. BMC Pediatr. 2022 May 19;22(1):294. doi: 10.1186/s12887-022-03355-6.
PubMed 35590259
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bowel And Bladder Function in Infant Toilet Training- a Randomized Intervention Study to Investigate the Efficacy of Assisted Infant Toilet Training on Preventing Functional Gastrointestinal and Urinary Tract Disorders up to 4 Years of Age
- ClinicalTrials.gov ID
- NCT04082689
- Acronym / sponsor ID
- BABITT / BABITT-01
- Keywords
- Colic, Constipation, Bladder dysfunction, Toilet training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 293 participants (actual)
- Lead sponsor
- Dalarna County Council, SwedenUniversity, hospital or other
- Collaborators
- Center for Clinical Research Dalarna, Sweden, Örebro University, Sweden, Göteborg University
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- Sep 2025 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial (RCT) where one group of children who begin assisted infant toilet training at age 0-2 months (group A) is compared to a group of children who begin assisted infant toilet training at 10-11 months (group B).
| Arm | Type | Receives |
|---|---|---|
| Assisted Infant Toilet Training-Group A | Active comparator | Behavioral: Assisted Infant Toilet TrainingParents 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. |
| Assisted Infant Toilet Training- Group B | Active comparator | Behavioral: Assisted Infant Toilet TrainingParents 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. |
Who may qualify
- Ages
- Up to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Full-term infant (born at gestational week 37+0 to 41+6)
Key exclusion criteria (4 listed)
- Infants with malformations or disorders that may affect the gastrointestinal or urinary tract in any relevant way
- Infants born small for gestational age (SGA), < - 2 standard deviation
- Parents with insufficient understanding of the Swedish language
- Infants older than 2 months, 1 week and 6 days at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted Infant Toilet TrainingAlso: Elimination CommunicationThe 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. | Behavioural | Assisted Infant Toilet Training- Group B, Assisted Infant Toilet Training-Group A |
Primary outcome
Prevalence of functional constipation
Time frame: Up to 9 months of age
Functional constipation, measured with validated questionnaires according to the ROME IV criteria
Prevalence of infant dyschezia
Time frame: Up to 9 months of age
Infant dyschezia, measured with validated questionnaires according to the ROME IV criteria
Prevalence of infant colic
Time frame: Up to 5 months of age
Infant colic measured with validated questionnaires according to the ROME IV criteria, including a prospective 24h infant behavioral diary when infant colic is suspected
4 secondary outcomes
Prevalence of functional constipation
Time frame: Up to 4 years of age
Prevalence of gastrointestinal symptoms
Time frame: At 4 years of age
Prevalence of stool toileting refusal
Time frame: At 4 years of age
Prevalence of bladder dysfunction
Time frame: Up to 4 years of age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Derived from this study: PubMed 41249012Nilsson T, Leijon A, LoMartire R, De la Calle Dahlstedt S, Sillen U, Hellstrom AL, Skogman BH. Assisted infant toilet training and the prevalence of functional gastrointestinal disorders up to the age of 9 months: a randomised, controlled trial. Arch Dis Child. 2026 Feb 19;111(3):238-244. doi: 10.1136/archdischild-2025-328792.
- Derived from this study: PubMed 35590259Nilsson T, Leijon A, Sillen U, Hellstrom AL, Skogman BH. Bowel and bladder function in infant toilet training (BABITT) - protocol for a randomized, two-armed intervention study. BMC Pediatr. 2022 May 19;22(1):294. doi: 10.1186/s12887-022-03355-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbro Hedin Skogman, assoc. prof. study director
Dalarna County Council, Sweden
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted Infant Toilet Training in people with Infantile Colic and Constipation - Functional, run by Dalarna County Council, Sweden at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of functional constipation (time frame: Up to 9 months of age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082689, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.