Functional constipation constituted 30% of pediatric gastroenterology office practice, 4-5% of all referrals to pediatric gastroenterology tertiary care centers and 0.8-1% of all pediatric cases in medical colleges. At the end of the meeting, it was decided to include these recommendations as a guideline on the evaluation and management of functional constipation in children in India. A writing group was designated for the same. The draft was sent by email to all experts and their suggestions were incorporated in the final guidelines.

Normal stool frequency: There are very few studies on normal stool frequency and consistency in Indian children. The average stool frequency of Indian children is as follows: <1 month age: 3-4 times/day; 1 month to 1 year age: 1.5-2 times/day; 1 to 2 year age: 1-2 times/day, mostly formed; older than 2 year age: 1 time/day [1,2].

Constipation: A delay or difficulty in defecation sufficient to cause significant distress to the patient is defined as constipation. When the duration of constipation is less than 4 week, it is labeled as acute constipation and when the duration is more, it is labeled as chronic constipation.

Based on the North American Society of Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) guidelines, Rome III criteria [3,4] and expert opinion, the definition recommended for application in Indian children is given in Box 1.

Refractory constipation: Constipation not responding to optimal conventional treatment for at least 3 months, despite good compliance [5]. These patients should be referred to a pediatric gastroenterologist for evaluation.

History and examination are relevant in making a diagnosis of constipation, differentiating functional and organic constipation, looking for precipitants of functional constipation and eliciting issues relevant to management like incontinence, impaction, past treatment, treatment compliance and response to treatment. Clinical features and their interpretation are shown in Table I.

TABLE I Characteristics of Functional and Organic Constipation

Dietary history: Details of diet should be taken: intake of fruits and vegetables and refined foods (e.g., bakery products), beverages etc. in older children, nature of feeds (breast vs top feeds) and details of supplementary feeds in younger babies. Exclusive and prolonged milk intake with minimal solids in young infants is a major factor causing functional constipation in India (unanimous opinion). These children are at an increased risk of iron deficiency anemia.

Patients should be examined thoroughly with proper growth assessment to rule out an organic etiology (Table I). Lower abdomen should be palpated for fecoliths (soft or hard indentable masses). In the absence of abdominal fecoliths, anal fissure or anal malformations, digital rectal examination (index finger in an older child or little finger in an infant) helps in the following: (a) presence of fecal impaction (seen in 50-70% children with functional constipation and is diagnosed in the presence of a hard mass (fecal mass) in the lower abdomen or presence of large, hard stools (fecolith) on Digital rectal examination (DRE), (b) diagnosis of Hirschprung’s disease (empty rectum, gush of stools/air on withdrawal of finger), and (c) sacral mass lesion (palpable mass). DRE is not essential in all cases or at all visits. It is recommended in the following instances: (a) red flag symptoms or signs, (b) onset <6 months of age, (c) non-responders despite good compliance to therapy, and (d) patients presenting with fecal incontinence to differentiate between constipation related and non-retentive incontinence [9-11].

Red flags suggestive of organic constipation: delayed passage of meconium, onset in early infancy, ribbon or pellet stools, bilious vomiting, uniform abdominal distension, failure to thrive, recurrent lower respiratory infections, cold intolerance, neuro-developmental delay or regression, gush of stools on DRE, anal malformations, abnormal neurological examination (paraspinal, lower limbs and anorectal reflexes). Details are given in Table I.

Investigations: 95% children with constipation have functional constipation and do not need any investigations. Children with red flags (as above) suggestive of organic etiology or those who are diagnosed as functional constipation but fail to respond to therapy need diagnostic evaluation. A plain erect Xray abdomen or barium enema is not required as a routine investigation in all cases. [12-14].

The following points should be addressed: patient counseling, toilet training, modifications in diet, drug management, and follow-up.

Salient pathophysiological aspects inclusive of objective of treatment should be explained to the parents. Parents should be clearly explained the cause of functional constipation, preferably with a diagram. Any precipitating factors identified should be eliminated or modified by appropriate advice (e.g. in a child with exclusive milk feeding, (semi) solid diet supplementation should be instituted; drugs causing constipation should be stopped; any psychosocial factor operating needs to be addressed).

Toilet training should not be started before 24 months of age; however, there is a variation in recommended age of training between 3-4 years. Follow the ‘Rule of 1’: Toilet training to be done by one person, one routine (5 min after each major meal), one place, one word e.g. pooh/potty etc. In a child with constipation: (a) make the child sit in the toilet, 2-3 times a day for 5-10 minutes after meals (within 30 minutes of meal intake), (b) make the defecation painless by treating anal fissures, if present, (c) sit in squatting position in the Indian toilet or with foot rest in English toilet/potty seat to have appropriate angulation of knees and thighs to facilitate expulsion of stools, (d) reward system (positive reinforcement) helps in motivating the child and avoiding child-parent conflict.

There are no well-conducted randomized controlled studies of diet and treatment of constipation. Daily fiber requirement is 0.5 gm/kg/day. Adequate intake of fiber-rich diet (cereals, whole pulses with bran, vegetables, salad and fruits) is recommended at the initial counseling. High fiber diet chart should be given to parents (as per local practice). Restrict milk and encourage intake of semi-solids and solids in younger children. Ensure adequate intake of water. Normal activity is recommended.

It consists of initial phase of disimpaction in patients with fecal impaction and a maintenance phase with laxatives.

Rationale of disimpaction: Completely clear the colon so that no residual hard fecal matter is retained. Thereafter the maintenance laxative therapy can keep the bowel moving and empty so that there is no retention. This enables rectum to achieve the normal diameter and tone for proper anorectal reflexes and pelvic floor coordination to facilitate normal stool expulsion

Options for Disimpaction: There are two ways of disimpaction (Table II) (a) one-time hospital based (100% success) (b) home based in split doses (68-97% success) [14,15,17]. Rarely rectal enemas can be used as supplementary therapy to clear the heavily hard loaded colorectal region. Oral route is preferred as it non-invasive, has better patient acceptability, cleans the entire colon and is equally effective as rectal disimpaction. Manual evacuation of rectum is rarely required in patients failing oral and rectal disimpaction but it should be performed under anaesthesia. Children undergoing disimpaction should be reviewed within one week of disimpaction to assess for re-impaction. Maintenance therapy should be started only after effective disimpaction.

TABLE II  Disimpaction

There are different classes of laxatives used for constipation (osmotic and stimulants).

Osmotic laxatives: These are the mainstay of maintenance therapy in children [5]. These laxatives draw water into the stool thereby making the stools softer and easy to pass. The two main osmotic laxatives are polyethylene glycol (PEG) and lactulose/lactitol (Table III). Based on the literature, and the experience of the group, the recommendations are: (i) PEG is the first line of therapy and is more effective as compared to lactulose/lactitol. However in children <1 year of age, the only drug recommended is lactulose/lactitol. (ii) In case of non-response or intolerance due to non-palatability to PEG, the second line of treatment is lactulose/lactitol which is safe for all ages. (iii) Two osmotic agents like PEG and lactulose/lactitol should not be given simultaneously. Combinations therapy with two classes of laxatives is not recommended for children [5].

TABLE III Osmotic Laxatives for Maintenance Therapy

Stimulant Laxatives: Stimulant laxatives are used only as rescue therapy No randomized controlled trials are available in children regarding their efficacy. Stimulants are usually required as rescue therapy (an acute or sudden episode of constipation while being on regular compliant maintenance therapy). These stimulants are given for a short duration of 2-3 days to tide over the acute episode of constipation, and then stopped (Table IV) [18].

TABLE IV Stimulant Laxatives: Rescue therapy

Behavioral therapy and biofeedback; These are helpful when constipation is associated with behavioral co-morbidity or pelvic floor dysfunction in older children and adolescents. This requires referral to centers with expertise.

Follow-up: Regular follow-up is essential. At each follow-up, record the stool history, associated symptoms, compliance with diet, medications and toilet-training. It is important to have a stool diary for proper follow-up. Parents should maintain a stool diary for objective assessment of response to therapy related to stool frequency and consistency. First follow-up is advised at 14 days to assess compliance. Subsequently, 1-2 monthly follow-up till normal bowel habit is attained or physician is satisfied with response as defined below as ‘successful outcome’. Further, 3-monthly follow-up for a minimum period of one year. While on follow-up, the maintenance dose may be increased or decreased to achieve daily passage of stools, keeping in view the features of successful outcome.

Successful outcome of treatment should be defined as (a) stool normalcy while on laxatives for a period of at least 4 weeks of initiation of therapy, and (b) achievement of stool normalcy for a minimum period of 6 months before tapering. Normalcy of stools should defined as daily, not-hard, nor loose watery stools, with absence of pain, straining, bleeding, posturing or incontinence.

In Western countries, 50% of children with functional constipation recover and are taken off medication within 6-12 months [19, 20]. About 25% continue to experience symptoms up to adult age [21]. Data from India show that 95% respond over a mean (SD) follow-up of 15.0 (16.7) months [14]. 18.4% patients have recurrence of symptoms on follow up; 10.5% of them require rescue disimpaction after a median duration of 5.5 (1.5-17) months of the first disimpaction [14].

When to stop laxatives: No clear guidelines exist and only expert opinions are available. Based on the natural history, child should have been symptom-free while on maintenance therapy for at least 6 months before attempting to taper the laxatives. It is then advisable to taper gradually over a period of 3 months. Laxatives should never be stopped abruptly. In the developmental stage of toilet training, medication should only be stopped once toilet training and establishment of a regular stooling pattern is achieved. Dietary and toilet training advice should continue even after stoppage of laxatives. Triggers and precipitating factors of functional constipation should have been adequately addressed. Parents should have the knowledge about the management and also risk of relapse of symptoms on stoppage of medication.

Refractory constipation: Those patients not responding to a sustained optimal medical management of functional constipation should be investigated for hypothyroidism, celiac disease, Hirschprung disease, Cow milk protein allergy in young children, lead poisoning and spinal abnormalities. These children also need evaluation for presence of slow colonic transit, pelvic dyssynergia and pseudo-obstruction, in centers with expertise.

Functional constipation should be diagnosed in the absence of red flags. Impacted (incontinent) and non-impacted subgroups should be identified. Management protocol should be adapted as per the algorithm shown in Fig. 1. Emphasis should be laid on toilet-training and importantly in counselling particularly related to long-term usage of medical therapy.

*Fecal impaction (seen in 50-70% children with functional constipation) is diagnosed in the presence of a hard mass (fecal mass) in the lower abdomen or presence of large, hard stools on DRE (fecolith); and ^Successful outcome defined as (a) stool normalcy while on laxatives for a period of at least after 4 weeks; initiation of therapy, and (b) achievement of stool normalcy for a minimum period of 6 months before tapering; PEG: polyethylene glycol (refer table 2); stimulant laxatives are not a part of the routine management of algorithm and should only be reserved for rescue therapy. Fig. 1 Algorithm for the management of childhood functional constipation.

Writing committee: Surender Kumar Yachha, Anshu Srivastava, Moinak Sen Sarma

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