Infantile ColicNCT01513304
Chiropractic Manual Therapy in Infantile Colic
A study testing Manual therapy in people with Infantile Colic, run by Professor Jennifer Bolton at 1 site in United Kingdom.
Trial summary
Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour. Read more about this study
- Who is it for?
- Ages Up to 8 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2007to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 weeks
- All sexes
- Child
Who may be able to join
- Excessive crying,
- infant less than 8weeks of age,
- born at gestational age 37 weeks or later, otherwise healthy
Who cannot join
- Not accepted for chiropractic care
Trial locations and contacts
1 site in 1 country.
About this study
Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.
- Conditions
- Infantile Colic
- Being tested
- Manual therapy
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic manual therapy | Experimental | Not described Receives: Procedure: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily crying diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startSep 2007
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
Sponsor and investigators
- Lead sponsor
- Professor Jennifer Bolton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Jennifer Bolton, Anglo-European College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513304
- Sponsor's protocol ID
- AECCRCT1
- Status last verified
- Jan 2012
- First submitted
- 17 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiropractic Manual Therapy in Infantile Colic
- ClinicalTrials.gov ID
- NCT01513304
- Acronym / sponsor ID
- AECCRCT1
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Professor Jennifer BoltonUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- May 2011 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
Efficacy of chiropractic manual therapy in infants with excessive crying behaviour. Influence of parental bias in reporting crying behaviour.
Study design
- Primary purpose
- Treatment
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chiropractic manual therapy | Experimental | Procedure: Manual therapy |
Who may qualify
- Ages
- Up to 8 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (3 listed)
- Excessive crying,
- infant less than 8weeks of age,
- born at gestational age 37 weeks or later, otherwise healthy
Key exclusion criteria (1 listed)
- Not accepted for chiropractic care
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 |
|---|---|---|
| Manual therapy | Procedure or surgery | Chiropractic manual therapy |
Primary outcome
Daily crying diary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Infantile Colic, run by Professor Jennifer Bolton at 1 site in United Kingdom.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily crying diary. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2012.