Infantile ColicPhase 2/3ACU-COLNCT01761331
Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial (ACU-COL)
A Phase 2/3 study testing Acupuncture in people with Infantile Colic, run by Lund University at 4 sites in Sweden.
Trial summary
The purpose of this prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic. Read more about this study
- Who is it for?
- Ages 2 to 8 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 4 sitesSweden
- Study dates
- Jan 2013to May 2015
- Phase
- Phase 2/3
- 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 2 to 8 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- otherwise healthy infants
- crying/fussing more than three hours/day more than three days in the same week
- has tried cow´s milk protein free diet for at least five days
Who cannot join
- born before week 36
- has tried acupuncture treatment
- dont gain weight properly
- taking other medicine than dimethicone or lactobacillus reuteri
- parents who don´t understand Swedish
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Arlöv vårdcentral, BVC
Arlöv, Skåne County, 232 38
Askims vårdcentral, BVC
Askim, Västra Götaland County, 436 32
Tullgårdens BVC
Karlskrona, 371 85
Valla Vårdcentral, BVC
Linköping, Östergötland County, 582 16
About this study
Official title: Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial Comparing Acupuncture in a Standardized Point, Acupuncture in Individually Chosen Points and no Acupuncture
The purpose of this prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic. Group A will get standardized minimal acupuncture in LI4, group B will get individualized acupuncture in different points according to symptoms and group C will not get acupuncture. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.
Read the detailed description
Infantile colic is a common problem, affecting 10-20% of newborns. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no safe and effective drug and the use of complementary medicine is increasing in spite of weak or no evidence. Acupuncture releases different neurotransmitters and hormones, is calming, gives pain reduction and affects digestion. Therefore it is reasonable that acupuncture can have effect in colic. Acupuncture in infantile colic has shown promising results in the few scientific trials conducted. These trials have evaluated the effect of standardized minimal acupuncture in the acupuncture points Large Intestine 4 (LI4) (two trials) or Stomach 36 (ST36) (one recent trial). In this prospective randomized three armed, multi center study performed at Child Health Centers in three towns, the effect of acupuncture in reducing symptoms in infants, 2-8 weeks old, with colic will be investigated. Two types of acupuncture: standardized minimal acupuncture in LI4 and individualized acupuncture in different points according to symptoms will be compared to an untreated group. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.
Parents will get information about the trial from nurses and doctors at Child Health Centers (CHC) or from a web-site (www.spädbarnskolik.se). Parents who are interested in letting their infant participate in the trial get further information and sign informed consent. The trial is approved by the ethical board at Lund University.
Infant´s crying, fussing, sleep, feeding and stooling will be registered in a diary during a baseline week. Infants who cry/fuss more than three hours/day, more than three days during this week is included and randomized. Beside their ordinary contacts with their Child Health Center (CHC), infants and their parents are invited to visit a study CHC twice a week for two weeks, where they meet a nurse for about 20 minutes. Parents can describe their situation, discuss the infant´s symptoms and get advice. This nurse is blinded to which group the infant is randomized to. She carries the baby to another room and hands over the infant to a nurse, trained in acupuncture. The acupuncture nurse randomizes the infants to one of three groups, following a randomization list produced by the research department at Lund University Hospital. Group A will get standardized minimal acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn. Group B will get individualized acupuncture in points chosen by the acupuncturists according to symptoms: maximum 5 needles are inserted about 3 mm in points recommended in a guideline produced for the trial after discussions with experienced pediatric acupuncturists. Needles are retained for maximum one minute. Group C will not get acupuncture but will otherwise be treated similarly: they will be with the acupuncture nurse for five minutes while she holds the hand of the baby and talks to it in a calm voice. The acupuncture nurse make notes about bleeding and other possible side effects, and if the baby is crying. After approximately five minutes the acupuncture nurse calls the study nurse who carries the baby back to the parents. At every visit the study nurse asks parents if they have noticed any side effects, and asks if parents believe their baby gets acupuncture or not.
During the two intervention weeks and one week after the last visit to the study CHC parents register the infants behavior daily in a diary. Statistical analyses will be made from the diaries.
- Conditions
- Infantile Colic
- Being tested
- Acupuncture
- Keywords
- infant, colic, crying, acupuncture, stooling, sleep
- Medical subject headings
- Colic, Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Minimal standardized acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn.
Individualized acupuncture: maximum 5 needles are inserted, about 3 mm deep, in points chosen by the acupuncturists according to symptoms, in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Standardized acupuncture | Active comparator | Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. Intervention: Infants in the standardized acupuncture group get minimal acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn. Receives: Other: Acupuncture |
| Group B: Individualized acupuncture | Active comparator | Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. Infants in the individualized acupuncture group get acupuncture in points chosen by the acupuncturists according to symptoms: maximum 5 needles are inserted about 3 mm in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute. Receives: Other: Acupuncture |
| Group C: No acupuncture | No intervention | Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. The nurse hold the infant´s hand and talks to it but no acupuncture is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in crying
Difference over time and between groups in reduction in % of colicky crying, crying and fussing in minutes/day
Measured: mean values for crying during the baseline week, during each of the two intervention weeks and during the week after the last treatment
Secondary outcomes (1)
change in stooling
The frequency of stooling per day
Measured: mean values for stooling during the baseline week, during each of the two intervention weeks and during the week after the last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Ekhagastiftelsen
- Responsible party
- Principal investigator, Kajsa Landgren, Lund University
- Investigators
- Kajsa Landgren, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761331
- Sponsor's protocol ID
- LU-HSC-KL2013
- Acronym
- ACU-COL
- Status last verified
- Jun 2016
- First submitted
- 29 Dec 2012
- Last updated
- 28 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Landgren K, Hallstrom I, Tiberg I. The effect of two types of minimal acupuncture on stooling, sleeping and feeding in infants with colic: secondary analysis of a multicentre RCT in Sweden (ACU-COL). Acupunct Med. 2021 Apr;39(2):106-115. doi: 10.1177/0964528420920308. Epub 2020 May 6.
PubMed 32375501Landgren K, Hallstrom I. Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL). Acupunct Med. 2017 Jun;35(3):171-179. doi: 10.1136/acupmed-2016-011208. Epub 2017 Jan 16.
PubMed 28093383Landgren K, Tiberg I, Hallstrom I. Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL. BMC Complement Altern Med. 2015 Sep 14;15:325. doi: 10.1186/s12906-015-0850-x.
PubMed 26370560
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Infantile Colic - a Three Armed Randomized Multi Center Trial Comparing Acupuncture in a Standardized Point, Acupuncture in Individually Chosen Points and no Acupuncture
- ClinicalTrials.gov ID
- NCT01761331
- Acronym / sponsor ID
- ACU-COL / LU-HSC-KL2013
- Conditions
- Infantile Colic
- Keywords
- infant, colic, crying, acupuncture, stooling, sleep
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Ekhagastiftelsen
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 4 Jan 2013 (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 prospective randomized three armed, multi center study is to compare the effect of two types of acupuncture and no acupuncture in 2-8 weeks old infants with infantile colic. Group A will get standardized minimal acupuncture in LI4, group B will get individualized acupuncture in different points according to symptoms and group C will not get acupuncture. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.
Detailed description
Infantile colic is a common problem, affecting 10-20% of newborns. Both the baby and the parents are suffering and there is a risk that the early relationship is disturbed. There is no safe and effective drug and the use of complementary medicine is increasing in spite of weak or no evidence. Acupuncture releases different neurotransmitters and hormones, is calming, gives pain reduction and affects digestion. Therefore it is reasonable that acupuncture can have effect in colic. Acupuncture in infantile colic has shown promising results in the few scientific trials conducted. These trials have evaluated the effect of standardized minimal acupuncture in the acupuncture points Large Intestine 4 (LI4) (two trials) or Stomach 36 (ST36) (one recent trial). In this prospective randomized three armed, multi center study performed at Child Health Centers in three towns, the effect of acupuncture in reducing symptoms in infants, 2-8 weeks old, with colic will be investigated. Two types of acupuncture: standardized minimal acupuncture in LI4 and individualized acupuncture in different points according to symptoms will be compared to an untreated group. Parents (who register the infants crying) and the nurse they meet at the study CHC are blinded.
Parents will get information about the trial from nurses and doctors at Child Health Centers (CHC) or from a web-site (www.spädbarnskolik.se). Parents who are interested in letting their infant participate in the trial get further information and sign informed consent. The trial is approved by the ethical board at Lund University.
Infant´s crying, fussing, sleep, feeding and stooling will be registered in a diary during a baseline week. Infants who cry/fuss more than three hours/day, more than three days during this week is included and randomized. Beside their ordinary contacts with their Child Health Center (CHC), infants and their parents are invited to visit a study CHC twice a week for two weeks, where they meet a nurse for about 20 minutes. Parents can describe their situation, discuss the infant´s symptoms and get advice. This nurse is blinded to which group the infant is randomized to. She carries the baby to another room and hands over the infant to a nurse, trained in acupuncture. The acupuncture nurse randomizes the infants to one of three groups, following a randomization list produced by the research department at Lund University Hospital. Group A will get standardized minimal acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn. Group B will get individualized acupuncture in points chosen by the acupuncturists according to symptoms: maximum 5 needles are inserted about 3 mm in points recommended in a guideline produced for the trial after discussions with experienced pediatric acupuncturists. Needles are retained for maximum one minute. Group C will not get acupuncture but will otherwise be treated similarly: they will be with the acupuncture nurse for five minutes while she holds the hand of the baby and talks to it in a calm voice. The acupuncture nurse make notes about bleeding and other possible side effects, and if the baby is crying. After approximately five minutes the acupuncture nurse calls the study nurse who carries the baby back to the parents. At every visit the study nurse asks parents if they have noticed any side effects, and asks if parents believe their baby gets acupuncture or not.
During the two intervention weeks and one week after the last visit to the study CHC parents register the infants behavior daily in a diary. Statistical analyses will be made from the diaries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Standardized acupuncture | Active comparator | Other: AcupunctureInfants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. Intervention: Infants in the standardized acupuncture group get minimal acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn. |
| Group B: Individualized acupuncture | Active comparator | Other: AcupunctureInfants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. Infants in the individualized acupuncture group get acupuncture in points chosen by the acupuncturists according to symptoms: maximum 5 needles are inserted about 3 mm in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute. |
| Group C: No acupuncture | No intervention | –Infants come to the clinic twice a week for three weeks. Parents meet a nurse and hand the infant to her. The nurse brings the infant to a room where another nurse, trained in acupuncture, is alone with the infant for five minutes. The nurse hold the infant´s hand and talks to it but no acupuncture is given. |
Who may qualify
- Ages
- 2 to 8 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- otherwise healthy infants
- crying/fussing more than three hours/day more than three days in the same week
- has tried cow´s milk protein free diet for at least five days
Key exclusion criteria (5 listed)
- born before week 36
- has tried acupuncture treatment
- dont gain weight properly
- taking other medicine than dimethicone or lactobacillus reuteri
- parents who don´t understand Swedish
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 |
|---|---|---|
| AcupunctureMinimal standardized acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn. Individualized acupuncture: maximum 5 needles are inserted, about 3 mm deep, in points chosen by the acupuncturists according to symptoms, in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute. | Other | Group A: Standardized acupuncture, Group B: Individualized acupuncture |
Primary outcome
change in crying
Time frame: mean values for crying during the baseline week, during each of the two intervention weeks and during the week after the last treatment
Difference over time and between groups in reduction in % of colicky crying, crying and fussing in minutes/day
1 secondary outcome
change in stooling
Time frame: mean values for stooling during the baseline week, during each of the two intervention weeks and during the week after the last treatment
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 28 Jun 2016.
- Derived from this study: PubMed 32375501Landgren K, Hallstrom I, Tiberg I. The effect of two types of minimal acupuncture on stooling, sleeping and feeding in infants with colic: secondary analysis of a multicentre RCT in Sweden (ACU-COL). Acupunct Med. 2021 Apr;39(2):106-115. doi: 10.1177/0964528420920308. Epub 2020 May 6.
- Derived from this study: PubMed 28093383Landgren K, Hallstrom I. Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL). Acupunct Med. 2017 Jun;35(3):171-179. doi: 10.1136/acupmed-2016-011208. Epub 2017 Jan 16.
- Derived from this study: PubMed 26370560Landgren K, Tiberg I, Hallstrom I. Standardized minimal acupuncture, individualized acupuncture, and no acupuncture for infantile colic: study protocol for a multicenter randomized controlled trial - ACU-COL. BMC Complement Altern Med. 2015 Sep 14;15:325. doi: 10.1186/s12906-015-0850-x.
- 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.
Kajsa Landgren, PhD principal investigator
Lund University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acupuncture in people with Infantile Colic, run by Lund University at 4 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 3 inclusion and 5 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 28 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
change in crying (time frame: mean values for crying during the baseline week, during each of the two intervention weeks and during the week after the last treatment). 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 NCT01761331, which also lists 3 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 28 Jun 2016.