Infantile ColicCHICNCT02138656
CHiropractic for Infantile Colic Study
A study testing Chiropractic in people with Infantile Colic, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether a course of chiropractic treatment has a significant impact on the natural course of infantile colic, specifically: 1. Do parents of colicky infants randomised to the groups receiving a course of McTimoney chiropractic treatment: report a significantly greater… Read more about this study
- Who is it for?
- Ages 1 day to 12 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Chiropractic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Dec 2014
- 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 1 day to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parentally-reported crying of more than three hours per day for three or more days in the preceding week (reported at initial contact to determine preliminary diagnosis of colic)
- Confirmation at first clinic visit that the infant has cried for more than three hours per day for at least one day in the base-lining period.
- Otherwise normal infants, born at term, with normal growth and development, and no indication of other underlying pathology
- Parents fluent in English, providing informed written consent
Who cannot join
- Infants who have received previous chiropractic, osteopathic or other manipulative treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Chiropractic in the Treatment of Infantile Colic
The purpose of this study is to investigate whether a course of chiropractic treatment has a significant impact on the natural course of infantile colic, specifically:
- Do parents of colicky infants randomised to the groups receiving a course of McTimoney chiropractic treatment:
Read more
- report a significantly greater improvement in hours of crying than those in the control group?
- report a significantly greater improvement their own quality of life (anxiety and depression)?
- report "resolution" of colic following treatment than the control group?
- What effect does parental blinding have on parentally-reported symptoms of infantile colic and parental quality of life?
The study will also include exploratory investigations to determine whether there are:
- Any particular groupings of patient characteristics (for example; 'other' presenting symptoms, position in the natural course of colic, age of onset, spinal dysfunction, perinatal factors) that are associated with good or poor outcomes
- Any particular characteristics of the treatment (e.g. specific adjustments) that are associated with good or poor outcomes.
Read the detailed description
Overall Design
The study will be a two-by-two factorial design combining groups of chiropractic treatment or 'Best Standard Care' with blinded or unblinded parents.
The two treatment groups will be 'Best Standard Care only' (BSC) and 'Best Standard Care plus chiropractic' (Chiro). Best standard care will be based on the recommendations from United Kingdom (UK) National Health Service (NHS), using the Map of Medicine care map. Chiropractic treatment will be delivered according to the protocol defined by the participating chiropractors.
There will be two blinded and two unblinded groups. The blinded BSC group will receive the 'sham' treatment in addition to the BSC counselling. The unblinded BSC group will not require this.
In addition, to allow the effects of the n-shaped curve inherent in the natural course of colic to be evaluated, all groups will be stratified by age at entry (below 4 weeks (expected increasing crying over the 2 weeks of the main intervention), between 4 and 6 weeks (expected plateau), and over 6 weeks (decreasing crying)).
The study has a longitudinal design over a ~4 1/2 week period.
For the primary outcomes which take data from the crying diaries, the main data points are defined as:
- Baseline: the 24 hour period of the day before the first treatment
- First treatment: the 24 hour period of the day after the first treatment
- Mid-point treatment: the 24 hour period of the day after the second treatment
- Final treatment: the 24 hour period of the day after the third treatment
Secondary outcomes will include data from the following points:
- Follow-up 1: the 24 hour period of the day 7 days after the third treatment
- Follow-up 2: the 24 hour period of the day 14 days after the third treatment
Other data will be sourced from:
- The initial visit questionnaires
- Follow-up questionnaires approximately 2 days after first treatment, 2 days after 2nd treatment, 2 days after final treatment, around day 21 and day 28.
Instruments
Data collection will be done through 8 main data collection instruments, drafts of which have now been developed:
- First contact questionnaire
- Crying Diary (including severity of other symptoms)
- Initial Visit Questionnaire - Part 1 (demographics and history)
- Initial Visit Questionnaire - Part 2 (success of blinding)
- Credibility and Expectancy Questionnaire (CEQ)
- Hospital Anxiety and Depression Scale
- Adjustments record
- Weekly telephone questionnaire
Power
The sample size is 160, calculated achieve 80% power, 5% significance level, and using an estimated standard deviation of around 2 (based on results from similar studies) for a 1 hour between-groups difference (identified as a 'clinically relevant reduction in crying time' from a parental survey) and allowing for a 25% attrition rate in the latter 2 weeks (based on experiences in similar studies).
Analysis:
Primary Outcomes
For the primary analyses comparisons will be carried out using all the data in one analysis which will assess the significance of the treatments, the blindness and the age groups in an ANCOVA. This will include interaction terms to assess whether the treatment effects are different for the different levels of blindness and for the different age groups and all baseline variables will be included as covariates.
A logistic regression analysis will be used to produce odds ratios for the comparison of treatment, blindness and age groups. The between-groups differences in proportion (risk ratio) of patients reporting 'complete resolution' of colic symptoms (PGIS) after first, mid-point and final treatments (primary outcome) and at follow ups (secondary outcomes) Adverse events will be reported with no analysis. Extraction of primary data from crying diaries will be performed by observers blinded to group allocation.
The primary analysis will be performed by a statistician blinded to group allocation.
Secondary Outcomes
The primary analysis of primary outcomes will be extended to days 21 and 28, as above.
The ANCOVA will be extended to evaluate the between-group differences in
- Cost of NHS resource usage
- Duration that the infant is fussy It is anticipated that parent compliance in completing the diary is likely to deteriorate during once the clinic visits have ceased. However, regular telephone calls will attempt to encourage continued completion. The primary study outcomes will be based on the first 15 days of the diary and it is anticipated that there will be greater compliance during this time.
Investigative Analysis
The exploratory investigations seek to establish any associations between the outcome measures (daily hours crying, presence of other symptoms, Parental Global Impressions of Severity (PGIS), Parental Global Impressions of Change (PGIC), and 'resolution' of colic) after first, mid-point and final treatments, and at follow-ups and any other predictor variables as gathered in the initial visit (Part 1). For example, :
- baseline daily hours crying
- initial symptom trajectory; worsening, plateau, improving
- baseline 'other symptoms' not at all, low, medium and high severity
- age at onset
- perinatal factors (Miller, 2007)
- treatment characteristics
Intention to treat v per protocol
Since this is a clinical study, the primary analysis will be done on an intention-to-treat basis, including any patients who fail to comply with the protocol for their group (e.g. dropping out of the treatment groups).
For some of the analyses, accurate data is required (e.g. actual adjustments performed) which cannot be imputed. In these cases, the analysis will be done on a per protocol basis.
Missing data
Previous studies have reported that the majority of dropouts occur in the no-treatment groups due to worsening symptoms and in the treatment groups due to resolution of symptoms, so data imputed at last value carried forward will represent a conservative approach. For the primary crying time outcome data, where there is a record for Day 8, this will be carried forward to Day 15.
Where reasons for withdrawal on the basis of worsening symptoms are given, this will be included as data points within the PGIS \& PGIC analysis, so no imputation will be required.
Attempts will be made to contact any drop-outs to ascertain their reasons for choosing not to continue in the study and these will be reported separately.
For the other analyses, a longitudinal analysis of variance will assess changes over time for the treatment, blindness and age groups together with any interactions and covariates. Although there may be some loss of data in the later time periods, a repeated measures analysis should be able to cope with this without imputation of missing data.
Numbers of subjects responding to the study and progressing to each stage will be recorded on a CONSORT-style flow diagram.
- Conditions
- Infantile Colic
- Being tested
- Chiropractic, Best Standard Care
- Keywords
- Crying, Chiropractic, Infant, pediatric, Infantile colic, Clinical Trial
- Medical subject headings
- Colic, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiropracticOther
Chiropractic treatment delivered in accordance with clinical protocols developed and agreed with the participant clinicians
Best Standard CareOther
Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic
| Study group | Role | What they receive |
|---|---|---|
| Best standard care only - not blind | Active comparator | Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice.
Parents aware that infant is not receiving chiropractic treatment Receives: Other: Best Standard Care |
| Best Standard Care and Sham - Blind | Sham comparator | Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus sham chiropractic treatment. Parents unaware of whether infant is receiving real treatment or sham. Receives: Other: Best Standard Care |
| BSC & Chiropractic - Not blind | Experimental | Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus real chiropractic treatment.
Parents aware that infant is receiving chiropractic treatment. Receives: Other: Chiropractic; Other: Best Standard Care |
| BSC & Chiropractic - Blind | Experimental | Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus real chiropractic treatment.
Parents not aware that infant is receiving chiropractic treatment. Receives: Other: Chiropractic; Other: Best Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes to the duration of crying per day
Measured: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)
Proportion of infants achieving clinically-relevant reduction in crying time
Defined as 60 minutes (median) based on survey
Measured: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)
Proportion of infants reported with absence of 'colic'
Taken from the Parental Global Impression of Severity scale
Measured: Follow-up telephone call after first, mid point and final clinic visit (approx days 2, 8 and 15)
Number of adverse events
Measured: at any time during an infant's engagement in the study, circa 28 days
Secondary outcomes (9)
Changes to the duration of crying per day
Measured: baseline to day 21 and day 28
Changes to parental anxiety and depression scores
Measured: first visit (day 1) to each of the 5 follow-up questionnaires (~day 2, 8, 15, 21 & 28)
Proportion of infants achieving clinically-relevant reduction in crying time
Measured: From baseline to day 21 and day 28 follow ups
Proportion of infants reported with absence of 'colic'
Measured: At day 21 and day 28 (final 2 follow-ups)
Parental Global Impressions of Change in symptoms
Measured: At each of the follow-up questionanaires (~day 2, 8, 15, 21 and 28)
Cost of NHS resources used
Costs calculated based on reported interactions and standard costs published annually by the Personal Social Services Research Unit (PSSRU) in the UK.
Measured: Reported 'during the preceding week' at each telephone questionnaire (~day 2, 8, 15, 21 and 28)
Change to Severity of colic-related specific symptoms
Based on 5-point likert scale 'not at all' to 'a very great deal' for crying with high pitched sound, crying with pain cry, pulling faces (apparently in pain), having a flushed face, holding breath, clenching fists, bending elbows/holding arms rigid, punching fists, wind milling arms, kicking legs, drawing legs up, arching back, tense/distended abdomen, borborygmus, flatulence, vomiting/regurgitating
Measured: Baseline to day after first, mid point and final clinic visits (~days 2, 8, 15) then to day 21 and day 28
Change to Parental Global Impressions of Severity
Measured: Baseline to follow-ups after first second and final clinic visits (~days 2, 8, 15) then to day 21 and day 28 follow ups
Effectiveness of Blinding
Proportion of correct, incorrect and 'don't know' guesses, reported using James' and Bangs' blinding indices
Measured: immediately after first "treatment" (day 1) and at follow-up telephone questionnaires after first, mid point and final clinic visits (~day 2, 8 and 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Review of recruitment methods
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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- McTimoney College of Chiropractic
- Responsible party
- Sponsor
- Investigators
- George Lewith, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138656
- Sponsor's protocol ID
- ERGO 4866
- Acronym
- CHIC
- Status last verified
- Apr 2021
- First submitted
- 28 Apr 2014
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Chiropractic in the Treatment of Infantile Colic
- ClinicalTrials.gov ID
- NCT02138656
- Acronym / sponsor ID
- CHIC / ERGO 4866
- Conditions
- Infantile Colic
- Keywords
- Crying, Chiropractic, Infant, pediatric, Infantile colic, Clinical Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Review of recruitment methods
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- McTimoney College of Chiropractic
- Study start
- Mar 2014 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 May 2014 (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.
The purpose of this study is to investigate whether a course of chiropractic treatment has a significant impact on the natural course of infantile colic, specifically:
- Do parents of colicky infants randomised to the groups receiving a course of McTimoney chiropractic treatment:
- report a significantly greater improvement in hours of crying than those in the control group?
- report a significantly greater improvement their own quality of life (anxiety and depression)?
- report "resolution" of colic following treatment than the control group?
- What effect does parental blinding have on parentally-reported symptoms of infantile colic and parental quality of life?
The study will also include exploratory investigations to determine whether there are:
- Any particular groupings of patient characteristics (for example; 'other' presenting symptoms, position in the natural course of colic, age of onset, spinal dysfunction, perinatal factors) that are associated with good or poor outcomes
- Any particular characteristics of the treatment (e.g. specific adjustments) that are associated with good or poor outcomes.
Detailed description
Overall Design
The study will be a two-by-two factorial design combining groups of chiropractic treatment or 'Best Standard Care' with blinded or unblinded parents.
The two treatment groups will be 'Best Standard Care only' (BSC) and 'Best Standard Care plus chiropractic' (Chiro). Best standard care will be based on the recommendations from United Kingdom (UK) National Health Service (NHS), using the Map of Medicine care map. Chiropractic treatment will be delivered according to the protocol defined by the participating chiropractors.
There will be two blinded and two unblinded groups. The blinded BSC group will receive the 'sham' treatment in addition to the BSC counselling. The unblinded BSC group will not require this.
In addition, to allow the effects of the n-shaped curve inherent in the natural course of colic to be evaluated, all groups will be stratified by age at entry (below 4 weeks (expected increasing crying over the 2 weeks of the main intervention), between 4 and 6 weeks (expected plateau), and over 6 weeks (decreasing crying)).
The study has a longitudinal design over a ~4 1/2 week period.
For the primary outcomes which take data from the crying diaries, the main data points are defined as:
- Baseline: the 24 hour period of the day before the first treatment
- First treatment: the 24 hour period of the day after the first treatment
- Mid-point treatment: the 24 hour period of the day after the second treatment
- Final treatment: the 24 hour period of the day after the third treatment
Secondary outcomes will include data from the following points:
- Follow-up 1: the 24 hour period of the day 7 days after the third treatment
- Follow-up 2: the 24 hour period of the day 14 days after the third treatment
Other data will be sourced from:
- The initial visit questionnaires
- Follow-up questionnaires approximately 2 days after first treatment, 2 days after 2nd treatment, 2 days after final treatment, around day 21 and day 28.
Instruments
Data collection will be done through 8 main data collection instruments, drafts of which have now been developed:
- First contact questionnaire
- Crying Diary (including severity of other symptoms)
- Initial Visit Questionnaire - Part 1 (demographics and history)
- Initial Visit Questionnaire - Part 2 (success of blinding)
- Credibility and Expectancy Questionnaire (CEQ)
- Hospital Anxiety and Depression Scale
- Adjustments record
- Weekly telephone questionnaire
Power
The sample size is 160, calculated achieve 80% power, 5% significance level, and using an estimated standard deviation of around 2 (based on results from similar studies) for a 1 hour between-groups difference (identified as a 'clinically relevant reduction in crying time' from a parental survey) and allowing for a 25% attrition rate in the latter 2 weeks (based on experiences in similar studies).
Analysis:
Primary Outcomes
For the primary analyses comparisons will be carried out using all the data in one analysis which will assess the significance of the treatments, the blindness and the age groups in an ANCOVA. This will include interaction terms to assess whether the treatment effects are different for the different levels of blindness and for the different age groups and all baseline variables will be included as covariates.
A logistic regression analysis will be used to produce odds ratios for the comparison of treatment, blindness and age groups. The between-groups differences in proportion (risk ratio) of patients reporting 'complete resolution' of colic symptoms (PGIS) after first, mid-point and final treatments (primary outcome) and at follow ups (secondary outcomes) Adverse events will be reported with no analysis. Extraction of primary data from crying diaries will be performed by observers blinded to group allocation.
The primary analysis will be performed by a statistician blinded to group allocation.
Secondary Outcomes
The primary analysis of primary outcomes will be extended to days 21 and 28, as above.
The ANCOVA will be extended to evaluate the between-group differences in
- Cost of NHS resource usage
- Duration that the infant is fussy It is anticipated that parent compliance in completing the diary is likely to deteriorate during once the clinic visits have ceased. However, regular telephone calls will attempt to encourage continued completion. The primary study outcomes will be based on the first 15 days of the diary and it is anticipated that there will be greater compliance during this time.
Investigative Analysis
The exploratory investigations seek to establish any associations between the outcome measures (daily hours crying, presence of other symptoms, Parental Global Impressions of Severity (PGIS), Parental Global Impressions of Change (PGIC), and 'resolution' of colic) after first, mid-point and final treatments, and at follow-ups and any other predictor variables as gathered in the initial visit (Part 1). For example, :
- baseline daily hours crying
- initial symptom trajectory; worsening, plateau, improving
- baseline 'other symptoms' not at all, low, medium and high severity
- age at onset
- perinatal factors (Miller, 2007)
- treatment characteristics
Intention to treat v per protocol
Since this is a clinical study, the primary analysis will be done on an intention-to-treat basis, including any patients who fail to comply with the protocol for their group (e.g. dropping out of the treatment groups).
For some of the analyses, accurate data is required (e.g. actual adjustments performed) which cannot be imputed. In these cases, the analysis will be done on a per protocol basis.
Missing data
Previous studies have reported that the majority of dropouts occur in the no-treatment groups due to worsening symptoms and in the treatment groups due to resolution of symptoms, so data imputed at last value carried forward will represent a conservative approach. For the primary crying time outcome data, where there is a record for Day 8, this will be carried forward to Day 15.
Where reasons for withdrawal on the basis of worsening symptoms are given, this will be included as data points within the PGIS \& PGIC analysis, so no imputation will be required.
Attempts will be made to contact any drop-outs to ascertain their reasons for choosing not to continue in the study and these will be reported separately.
For the other analyses, a longitudinal analysis of variance will assess changes over time for the treatment, blindness and age groups together with any interactions and covariates. Although there may be some loss of data in the later time periods, a repeated measures analysis should be able to cope with this without imputation of missing data.
Numbers of subjects responding to the study and progressing to each stage will be recorded on a CONSORT-style flow diagram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Best standard care only - not blind | Active comparator | Other: Best Standard CareBest Standard Care (as defined by Map of Medicine care pathway) - counseling and advice. Parents aware that infant is not receiving chiropractic treatment |
| Best Standard Care and Sham - Blind | Sham comparator | Other: Best Standard CareBest Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus sham chiropractic treatment. Parents unaware of whether infant is receiving real treatment or sham. |
| BSC & Chiropractic - Not blind | Experimental | Other: Chiropractic, Other: Best Standard CareBest Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus real chiropractic treatment. Parents aware that infant is receiving chiropractic treatment. |
| BSC & Chiropractic - Blind | Experimental | Other: Chiropractic, Other: Best Standard CareBest Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus real chiropractic treatment. Parents not aware that infant is receiving chiropractic treatment. |
Who may qualify
- Ages
- 1 day to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parentally-reported crying of more than three hours per day for three or more days in the preceding week (reported at initial contact to determine preliminary diagnosis of colic)
- Confirmation at first clinic visit that the infant has cried for more than three hours per day for at least one day in the base-lining period.
- Otherwise normal infants, born at term, with normal growth and development, and no indication of other underlying pathology
- Parents fluent in English, providing informed written consent
Key exclusion criteria (1 listed)
- Infants who have received previous chiropractic, osteopathic or other manipulative treatment
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 |
|---|---|---|
| ChiropracticChiropractic treatment delivered in accordance with clinical protocols developed and agreed with the participant clinicians | Other | BSC & Chiropractic - Blind, BSC & Chiropractic - Not blind |
| Best Standard CareCounselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic | Other | BSC & Chiropractic - Blind, BSC & Chiropractic - Not blind, Best Standard Care and Sham - Blind, Best standard care only - not blind |
Primary outcome
Changes to the duration of crying per day
Time frame: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)
Proportion of infants achieving clinically-relevant reduction in crying time
Time frame: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)
Defined as 60 minutes (median) based on survey
Proportion of infants reported with absence of 'colic'
Time frame: Follow-up telephone call after first, mid point and final clinic visit (approx days 2, 8 and 15)
Taken from the Parental Global Impression of Severity scale
Number of adverse events
Time frame: at any time during an infant's engagement in the study, circa 28 days
9 secondary outcomes
Changes to the duration of crying per day
Time frame: baseline to day 21 and day 28
Changes to parental anxiety and depression scores
Time frame: first visit (day 1) to each of the 5 follow-up questionnaires (~day 2, 8, 15, 21 & 28)
Proportion of infants achieving clinically-relevant reduction in crying time
Time frame: From baseline to day 21 and day 28 follow ups
Proportion of infants reported with absence of 'colic'
Time frame: At day 21 and day 28 (final 2 follow-ups)
Parental Global Impressions of Change in symptoms
Time frame: At each of the follow-up questionanaires (~day 2, 8, 15, 21 and 28)
Cost of NHS resources used
Time frame: Reported 'during the preceding week' at each telephone questionnaire (~day 2, 8, 15, 21 and 28)
Change to Severity of colic-related specific symptoms
Time frame: Baseline to day after first, mid point and final clinic visits (~days 2, 8, 15) then to day 21 and day 28
Change to Parental Global Impressions of Severity
Time frame: Baseline to follow-ups after first second and final clinic visits (~days 2, 8, 15) then to day 21 and day 28 follow ups
Effectiveness of Blinding
Time frame: immediately after first "treatment" (day 1) and at follow-up telephone questionnaires after first, mid point and final clinic visits (~day 2, 8 and 15)
Results and safety
The study was stopped early (reason given: Review of recruitment methods). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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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.
George Lewith principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic in people with Infantile Colic, run by University of Southampton 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 4 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: stopped early, as of the sponsor's last update on 26 Apr 2021. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Review of recruitment methods). Results are not available in the source record.
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?
Changes to the duration of crying per day (time frame: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)). The study lists 4 primary outcomes in all. 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 26 Apr 2021.